Deerfield, IL, United States
Baxter Healthcare Corporation recalls
182 recalls recorded since 2018, most recently on 14 September 2026. 114 are listed as ongoing. Status and classification are as published by the FDA.
Recalls182
Ongoing (FDA)114
Terminated or completed68
Class I (FDA)34
Ongoing Class II Medical devices
- Recall started
- 14 September 2026
- Reason
- Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0151-2027
- Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3264-2026, Z-3262-2026, Z-3263-2026
- PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned
- PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is re
- PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned
Ongoing Class I Drugs
- Recall started
- 17 August 2026
- Reason
- Presence of particulate matter: Particulates identified as fiberglass
- Distribution
- Natonwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0849-2026
- 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Ongoing Class I Drugs
- Recall started
- 17 August 2026
- Reason
- Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
- Distribution
- U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0850-2026
- Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
Ongoing Class II Medical devices
- Recall started
- 11 August 2026
- Reason
- A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3065-2026, Z-3066-2026
- Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Ongoing Class II Drugs
- Recall started
- 6 August 2026
- Reason
- CGMP Deviations
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0815-2026, D-0811-2026, D-0821-2026, D-0813-2026, D-0812-2026, D-0807-2026, D-0814-2026, D-0808-2026, D-0810-2026, D-0817-2026, D-0806-2026, D-0809-2026 and 5 more
- Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
- Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
- Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-96
- Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 430
- Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
- and 9 more product lines
Ongoing Class II Medical devices
- Recall started
- 3 August 2026
- Reason
- Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
- Distribution
- US Nationwide distribution in the states of Colorado and Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3257-2026
- Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Ongoing Class I Drugs
- Recall started
- 24 July 2026
- Reason
- Presence of Particulate Matter
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0787-2026
- Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 6001
Ongoing Class I Medical devices
- Recall started
- 30 June 2026
- Reason
- Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- Distribution
- US Nationwide. No OUS consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2766-2026
- Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Ongoing Class I Medical devices
- Recall started
- 21 May 2026
- Reason
- There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2550-2026, Z-2551-2026, Z-2548-2026, Z-2549-2026
- Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Ongoing Class II Medical devices
- Recall started
- 22 April 2026
- Reason
- Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Caroli
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2262-2026
- Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or
Ongoing Class II Medical devices
- Recall started
- 21 April 2026
- Reason
- The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
- Distribution
- Worldwide - US Nationwide distribution in the states of Minnesota, Maryland, and Pennsylvania and the countries of Canada, Hong Kong, India, Japan, Korea, Philippines, Taiwan, Thailand, Vietnam, Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iraq, Isra
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2638-2026
- Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables
Ongoing Class I Medical devices
- Recall started
- 18 February 2026
- Reason
- Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
- Distribution
- Florida
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1637-2026
- Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Ongoing Class II Medical devices
- Recall started
- 18 February 2026
- Reason
- Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CO, IL, IN, KS, MA, NE, NJ, NM, NY, PA, SC, TX, VA and the countries of Colombia and India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1573-2026
- Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, F
Ongoing Class II Medical devices
- Recall started
- 13 January 2026
- Reason
- Pumps were released without full testing being performed, including occlusion alarm testing.
- Distribution
- States: Ohio Countries: United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1368-2026
- Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Ongoing Class II Drugs
- Recall started
- 22 December 2025
- Reason
- Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0296-2026
- Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Ongoing Class II Medical devices
- Recall started
- 28 November 2025
- Reason
- Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1121-2026
- SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Ongoing Class II Medical devices
- Recall started
- 28 October 2025
- Reason
- Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
- Distribution
- US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0847-2026
- Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Ongoing Class II Medical devices
- Recall started
- 17 September 2025
- Reason
- Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
- Distribution
- Distribution US nationwide, Canada and Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0233-2026
- Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers
Ongoing Class II Medical devices
- Recall started
- 29 August 2025
- Reason
- IV sets may leak.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0190-2026, Z-0194-2026, Z-0195-2026, Z-0198-2026, Z-0193-2026, Z-0202-2026, Z-0204-2026, Z-0203-2026, Z-0189-2026, Z-0197-2026, Z-0200-2026, Z-0192-2026 and 4 more
- CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
- CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
- CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
- CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
- CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
- and 8 more product lines
Ongoing Class II Drugs
- Recall started
- 20 August 2025
- Reason
- Discoloration
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0596-2025
- Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Ongoing Class II Medical devices
- Recall started
- 8 August 2025
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2594-2025
- Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Ongoing Class I Medical devices
- Recall started
- 4 August 2025
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
- Distribution
- US distribution including Puerto Rico and OUS (International) Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2333-2025, Z-2332-2025, Z-2334-2025
- Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
- Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump
- Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Ongoing Class I Medical devices
- Recall started
- 14 July 2025
- Reason
- Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2173-2025
- Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Ongoing Class II Medical devices
- Recall started
- 14 July 2025
- Reason
- Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
- Distribution
- US distribution to states of: AZ, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2415-2025
- Spectrum IQ Infusion Pump, Product Code 3570009
Ongoing Class I Medical devices
- Recall started
- 20 June 2025
- Reason
- Certain Spectrum infusion pumps may have an incorrect version of software.
- Distribution
- US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2095-2025, Z-2096-2025
- Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Ongoing Class I Medical devices
- Recall started
- 30 May 2025
- Reason
- The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2032-2025, Z-2031-2025
- Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3)
- Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobi
Ongoing Class II Medical devices
- Recall started
- 12 May 2025
- Reason
- Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1964-2025
- Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Ongoing Class II Medical devices
- Recall started
- 9 May 2025
- Reason
- The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1962-2025
- 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Ongoing Class II Medical devices
- Recall started
- 6 May 2025
- Reason
- There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
- Distribution
- Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1816-2025
- Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444,
Ongoing Class I Medical devices
- Recall started
- 24 April 2025
- Reason
- There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1767-2025
- Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Ongoing Class I Medical devices
- Recall started
- 7 April 2025
- Reason
- A cybersecurity vulnerability was discovered through internal testing.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1726-2025, Z-1725-2025
- Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
- Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
Ongoing Class II Medical devices
- Recall started
- 24 March 2025
- Reason
- There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1558-2025, Z-1559-2025, Z-1560-2025
- Welch Allyn Connex Vital Signs Monitor (CVSM):
- Welch Allyn CONNEX Accessory Power Management Stand:
- Welch Allyn CP150 Electrocardiograph:
Ongoing Class II Medical devices
- Recall started
- 21 March 2025
- Reason
- Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1564-2025, Z-1563-2025, Z-1567-2025, Z-1568-2025, Z-1565-2025, Z-1566-2025, Z-1562-2025
- Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B; 4) ) Product Code/Part # 67MXXX-B
- Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B;
- Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23,
- Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/P
- Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
- Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
- Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; 4) 84MTVE2-US; 5) 84MTVEC-6; 6) 84MTVEC-B; 7) 84MTVEP-B; 8) 84MTVEX-4; 9) 84MTVX2-4; 10
Ongoing Class II Medical devices
- Recall started
- 3 March 2025
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
- Distribution
- US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1423-2025
- Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Ongoing Class II Medical devices
- Recall started
- 25 February 2025
- Reason
- There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1419-2025, Z-1413-2025, Z-1422-2025, Z-1410-2025, Z-1416-2025, Z-1418-2025, Z-1414-2025, Z-1421-2025, Z-1409-2025, Z-1417-2025, Z-1420-2025, Z-1411-2025 and 2 more
- Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
- Baxter Mobile column TruSystem 7500 U, Product Code 1730720
- Baxter TruSystem 7500, Product Code 4091000
- Baxter Stationary column TruSystem 7500, Product Code 1717020
- Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
- Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
- Baxter Stationary column TruSystem 7500 U, Product Code 1730731
- Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 25 February 2025
- Reason
- The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1468-2025
- Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31,
Ongoing Class I Medical devices
- Recall started
- 5 February 2025
- Reason
- There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- Distribution
- US: Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1253-2025, Z-1254-2025
- Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Ongoing Class I Medical devices
- Recall started
- 20 December 2024
- Reason
- There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- Distribution
- US, Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0884-2025, Z-0887-2025, Z-0886-2025, Z-0885-2025
- Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
- Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
- Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
- Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
Ongoing Class II Medical devices
- Recall started
- 20 December 2024
- Reason
- Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
- Distribution
- US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1011-2025, Z-1009-2025, Z-1010-2025
- Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
- Baxter Solution Set with Duo-Vent Spike, REF 2R8404
- Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Ongoing Class II Medical devices
- Recall started
- 19 November 2024
- Reason
- Devices were identified as released after repair without full testing being performed, which includes flow testing.
- Distribution
- US Nationwide distribution in the states of AL, IN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0776-2025, Z-0775-2025
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Ongoing Class II Drugs
- Recall started
- 30 October 2024
- Reason
- Labeling: Missing Label
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0039-2025
- Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation,
Ongoing Class II Medical devices
- Recall started
- 23 October 2024
- Reason
- There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0560-2025, Z-0559-2025, Z-0569-2025, Z-0562-2025, Z-0568-2025, Z-0564-2025, Z-0561-2025, Z-0565-2025, Z-0563-2025, Z-0566-2025, Z-0567-2025
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
- and 3 more product lines
Ongoing Class I Medical devices
- Recall started
- 21 October 2024
- Reason
- Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Distribution
- Worldwide Distribution (US Nationwide distribution)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0373-2025, Z-0375-2025, Z-0377-2025, Z-0379-2025, Z-0378-2025, Z-0382-2025, Z-0376-2025, Z-0381-2025, Z-0374-2025, Z-0380-2025
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
- and 2 more product lines
Ongoing Class I Medical devices
- Recall started
- 16 October 2024
- Reason
- Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
- Distribution
- US Nationwide distribution and worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0327-2025
- Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Ongoing Class II Medical devices
- Recall started
- 11 October 2024
- Reason
- There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0323-2025, Z-0321-2025, Z-0324-2025, Z-0322-2025, Z-0320-2025, Z-0325-2025
- Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
- Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
- Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
- Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
- Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
- Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Ongoing Class II Medical devices
- Recall started
- 2 October 2024
- Reason
- The door on the Spectrum IQ Infusion pump may not be able to fully close.
- Distribution
- GA, ID
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0348-2025
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Ongoing Class II Medical devices
- Recall started
- 19 September 2024
- Reason
- The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0216-2025, Z-0217-2025, Z-0215-2025, Z-0214-2025, Z-0211-2025, Z-0213-2025, Z-0210-2025, Z-0212-2025, Z-0218-2025
- Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
- Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
- Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
- Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
- Baxter Operating Table TruSystem 7000, Product code REF 1841046
- Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
- Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
- Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 September 2024
- Reason
- The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
- Distribution
- Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0228-2025
- a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P790
Ongoing Class I Medical devices
- Recall started
- 12 September 2024
- Reason
- The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0046-2025
- Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Ongoing Class I Medical devices
- Recall started
- 20 August 2024
- Reason
- Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3085-2024, Z-3083-2024, Z-3084-2024, Z-3082-2024
- Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
- Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
- Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
- Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
Ongoing Class I Drugs
- Recall started
- 1 August 2024
- Reason
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0649-2024
- Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Ongoing Class II Medical devices
- Recall started
- 17 July 2024
- Reason
- The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
- Distribution
- US, Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2582-2024, Z-2581-2024
- Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)
- Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pum
Ongoing Class II Medical devices
- Recall started
- 28 June 2024
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2512-2024
- Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Ongoing Class II Drugs
- Recall started
- 17 June 2024
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- Distribution
- US Nationwide, Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0587-2024
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457
Ongoing Class II Medical devices
- Recall started
- 14 June 2024
- Reason
- Improperly performed testing prior to release
- Distribution
- US Nationwide distribution in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2530-2024
- Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Ongoing Class II Medical devices
- Recall started
- 13 June 2024
- Reason
- The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
- Distribution
- Distributed to United States, Canada, Australia, Malaysia, New Zealand, Philippines, Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, and United Kingdom. UPDATED PER EMAIL DATED 7/24/2024: United States (including Puerto Rico and Guam), Canada, Australia, Brunei, Hong
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2339-2024
- Braun Thermoscan¿ PRO 6000 Ear Thermometer
Ongoing Class II Medical devices
- Recall started
- 4 June 2024
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2314-2024, Z-2315-2024, Z-2313-2024
- Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
- iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 406831
- VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
Ongoing Class II Medical devices
- Recall started
- 3 June 2024
- Reason
- During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
- Distribution
- Distribution to Illinois.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2323-2024
- Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
Ongoing Class I Medical devices
- Recall started
- 30 May 2024
- Reason
- Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
- Distribution
- Nationwide distribution. International distribution to Canada, France, and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2321-2024, Z-2322-2024
- Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
- Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Ongoing Class I Medical devices
- Recall started
- 29 May 2024
- Reason
- Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2140-2024
- Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000
Ongoing Class II Medical devices
- Recall started
- 8 May 2024
- Reason
- There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
- Distribution
- Distribution was made nationwide. There was also government/military distribution. Foreign distribution was made to Australia, Canada, China, Japan, Qatar, Saudi Arabia, Singapore, Taiwan, Turkey, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2151-2024
- Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ ma
Ongoing Class II Medical devices
- Recall started
- 9 April 2024
- Reason
- There is a potential for cracks on the mount of the front panel of the device.
- Distribution
- US Nationwide distribution in the states of Ohio, Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1810-2024
- Spectrum IQ Infusion pump, Product Code 357009
Ongoing Class II Medical devices
- Recall started
- 26 March 2024
- Reason
- Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Distribution
- Global, US: NY, IL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1509-2024, Z-1511-2024, Z-1510-2024
- Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,
- Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716012; d) POWER CORD
- Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER
Ongoing Class II Medical devices
- Recall started
- 20 March 2024
- Reason
- One device was improperly performed testing prior to release from a Service Center.
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1775-2024
- Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Ongoing Class II Medical devices
- Recall started
- 15 March 2024
- Reason
- Product was distributed in the United States without proper regulatory approval.
- Distribution
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1689-2024
- Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Ongoing Class II Medical devices
- Recall started
- 11 March 2024
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.
- Distribution
- US Nationwide distribution in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1329-2024
- HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Ongoing Class II Medical devices
- Recall started
- 5 March 2024
- Reason
- Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.
- Distribution
- US Nationwide distribution in the state of Colorado.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1400-2024
- Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Ongoing Class II Medical devices
- Recall started
- 28 February 2024
- Reason
- A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
- Distribution
- US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1378-2024, Z-1379-2024, Z-1377-2024, Z-1380-2024
- Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
- Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
- Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
- Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Ongoing Class II Medical devices
- Recall started
- 22 February 2024
- Reason
- The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1522-2024, Z-1523-2024, Z-1524-2024
- Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US ve
- Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US ve
- Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US ve
Ongoing Class II Medical devices
- Recall started
- 14 February 2024
- Reason
- Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
- Distribution
- US Nationwide distribution in the state of Alabama.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1289-2024
- STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Ongoing Class II Medical devices
- Recall started
- 8 February 2024
- Reason
- Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1291-2024
- CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Ongoing Class II Drugs
- Recall started
- 23 January 2024
- Reason
- Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0336-2024
- Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Ongoing Class I Medical devices
- Recall started
- 22 December 2023
- Reason
- An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
- Distribution
- US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1001-2024, Z-1002-2024
- Baxter Exactamix Pro 1200, REF EXM12DY
- Baxter Exactamix Pro 2400, REF EXM24DY
Ongoing Class II Medical devices
- Recall started
- 8 December 2023
- Reason
- Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
- Distribution
- United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0707-2024, Z-0705-2024, Z-0706-2024
- XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI
- Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX:
- XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d)
Ongoing Class II Medical devices
- Recall started
- 6 December 2023
- Reason
- Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0663-2024, Z-0661-2024, Z-0666-2024, Z-0667-2024, Z-0656-2024, Z-0668-2024, Z-0657-2024, Z-0669-2024, Z-0660-2024, Z-0658-2024, Z-0659-2024, Z-0664-2024 and 2 more
- Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Prod
- Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
- Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS
- Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883
- Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM,
- PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM
- Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
- Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 15 November 2023
- Reason
- There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0550-2024
- Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Completed Class II Drugs
- Recall started
- 14 November 2023
- Reason
- Failed pH Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0146-2024
- Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382
Ongoing Class I Medical devices
- Recall started
- 13 October 2023
- Reason
- Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
- Distribution
- US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0151-2024
- Novum IQ Syringe infusion system, Product Code 40800BAXUS
Ongoing Class II Medical devices
- Recall started
- 4 October 2023
- Reason
- Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.
- Distribution
- US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0212-2024
- HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A00
Terminated Class II Drugs
- Recall started
- 24 August 2023
- Terminated
- 22 December 2025
- Reason
- CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0048-2024
- Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
Completed Class III Drugs
- Recall started
- 14 August 2023
- Reason
- Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- Distribution
- Nationwide in the U.S.A.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1103-2023
- Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Terminated Class II Drugs
- Recall started
- 11 August 2023
- Terminated
- 16 July 2024
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1141-2023, D-1140-2023
- Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
- DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from being used temporarily on software versions v6.1.x, v6.2.x, and v7.0.x of the E3 user interface.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AL, AR, AZ, CA, CA, CT, FL, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MO, MS, MT, NE, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Canada and Bermuda.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2647-2023
- Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
- Distribution
- US Nationwide distribution in the state of CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2581-2023
- Welch Allyn Connex Spot Monitor
Ongoing Class II Medical devices
- Recall started
- 19 June 2023
- Reason
- An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2208-2023
- GEM FLOW COUPLER Monitor, PN 5156-00000-011
Ongoing Class I Medical devices
- Recall started
- 15 June 2023
- Reason
- A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2104-2023, Z-2103-2023
- The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Ongoing Class II Medical devices
- Recall started
- 19 May 2023
- Reason
- Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
- Distribution
- US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2007-2023, Z-2006-2023
- NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
- Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Ongoing Class II Medical devices
- Recall started
- 18 May 2023
- Reason
- Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, Denmark, Egypt, France, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, So
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2109-2023
- Allen Advance Chest Support with Pad
Ongoing Class II Medical devices
- Recall started
- 31 March 2023
- Reason
- There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Qatar.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1482-2023
- Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P32
Ongoing Class II Medical devices
- Recall started
- 27 March 2023
- Reason
- The product is brittle and potentially crumbling upon handling or when being removed from its package.
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1461-2023
- GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Ongoing Class II Medical devices
- Recall started
- 20 March 2023
- Reason
- ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1420-2023
- ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
Completed Class II Drugs
- Recall started
- 15 March 2023
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0543-2023, D-0542-2023
- Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
- Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container ba
Ongoing Class II Medical devices
- Recall started
- 22 February 2023
- Reason
- The electrical safety testing was not properly performed on the impacted devices and additional testing is required
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1316-2023
- Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.
- Distribution
- US Nationwide distribution and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1213-2023
- Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Ongoing Class I Medical devices
- Recall started
- 25 January 2023
- Reason
- There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1141-2023, Z-1140-2023, Z-1139-2023, Z-1142-2023
- Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
- Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
- Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
- Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
Ongoing Class II Medical devices
- Recall started
- 23 November 2022
- Reason
- Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0762-2023, Z-0763-2023, Z-0764-2023
- Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Ongoing Class II Medical devices
- Recall started
- 23 November 2022
- Reason
- Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
- Distribution
- Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecua
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0761-2023, Z-0760-2023
- Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
- Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Terminated Class II Medical devices
- Recall started
- 31 October 2022
- Terminated
- 6 March 2025
- Reason
- One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- Distribution
- TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1013-2023
- Baxter Electrocardiograph, ELI 380 -DCS21
Ongoing Class II Medical devices
- Recall started
- 18 October 2022
- Reason
- The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur with a patient weight of less than 500 lbs. depending on the patient 's position on the bed.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, IN, LA, MA, MO, NC, NM, NV, NY, OK, OR, PA, SC. TN, TX, WA, and WI. (UPDATED: States of PA and SC and there was government distribution.) There was no military distribution. Foreign distribution was made to Canada, Qatar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0231-2023
- Hill-Rom Progressa Bed System
Ongoing Class I Medical devices
- Recall started
- 30 September 2022
- Reason
- Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0143-2023, Z-0142-2023, Z-0141-2023, Z-0145-2023, Z-0144-2023
- Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
- Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
- Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7
- Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
- Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
Terminated Class II Medical devices
- Recall started
- 20 September 2022
- Terminated
- 4 August 2026
- Reason
- the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
- Distribution
- MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0180-2023, Z-0177-2023, Z-0175-2023, Z-0179-2023, Z-0176-2023, Z-0178-2023
- Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
- Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
- Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
- Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
- C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
- Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
Ongoing Class II Medical devices
- Recall started
- 14 September 2022
- Reason
- Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0085-2023, Z-0084-2023, Z-0081-2023, Z-0082-2023, Z-0083-2023
- Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
- Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.
- Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
- Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
- Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
Ongoing Class III Medical devices
- Recall started
- 2 September 2022
- Reason
- Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
- Distribution
- US Nationwide Distribution and government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1817-2022
- Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMAS
Terminated Class I Medical devices
- Recall started
- 9 August 2022
- Terminated
- 9 August 2024
- Reason
- Firm noted an increase in customer reports of leaks.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1653-2022
- Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Terminated Class II Drugs
- Recall started
- 4 August 2022
- Terminated
- 16 July 2024
- Reason
- Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1348-2022
- Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Ongoing Class II Medical devices
- Recall started
- 22 July 2022
- Reason
- There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
- Distribution
- Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1578-2022, Z-1579-2022, Z-1576-2022, Z-1581-2022, Z-1577-2022, Z-1575-2022, Z-1580-2022
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
Ongoing Class II Medical devices
- Recall started
- 14 July 2022
- Reason
- There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
- Distribution
- Worldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil, Colombia, Dominican Republic, Panama, Puerto Rico, Hong Kong, Taiwan, Korea, United Kingdom, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Kuwait, Netherlands, Oman, Pola
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1570-2022
- The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not inte
Ongoing Class II Medical devices
- Recall started
- 24 June 2022
- Reason
- The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1411-2022, Z-1413-2022, Z-1417-2022, Z-1416-2022, Z-1415-2022, Z-1414-2022, Z-1412-2022
- Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
- Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
- Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
- Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
- Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
- Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
- Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
Terminated Class I Medical devices
- Recall started
- 22 June 2022
- Terminated
- 9 October 2024
- Reason
- There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
- Distribution
- United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1376-2022
- ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 83
Ongoing Class II Medical devices
- Recall started
- 31 May 2022
- Reason
- An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.
- Distribution
- nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1306-2022
- NaviCare Nurse Call/Voalte Nurse Call
Terminated Class II Medical devices
- Recall started
- 17 May 2022
- Terminated
- 4 May 2026
- Reason
- Packaging error.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan, Canada, Australia, New Zealand, Spain, Brunei Darussalam, Brazil, India, Colombia, Czechia, Egypt, Turkey, South Africa, Argentina, Mexico, Congo, United Arab Emirates, El Salvador, South Korea, Germany, Cameroon, Guyana, Austria, B
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1288-2022
- #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Terminated Class I Medical devices
- Recall started
- 26 April 2022
- Terminated
- 20 August 2024
- Reason
- There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
- Distribution
- US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1139-2022, Z-1138-2022
- In-Line ventilator adaptor
- In-Line ventilator adaptor
Terminated Class II Medical devices
- Recall started
- 21 April 2022
- Terminated
- 27 May 2026
- Reason
- Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
- Distribution
- US Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1145-2022, Z-1141-2022, Z-1146-2022, Z-1142-2022, Z-1143-2022, Z-1144-2022
- 3,65 m Extension Set with Luer-lock Connector
- 15 Liters Drain Bag
- APD Drain Manifold
- Locking Cap for PD Catheter Adapter
- 5 Prong Manifold Set (with Luer Connectors)
- Effluent Sample Bag
Terminated Class II Medical devices
- Recall started
- 13 April 2022
- Terminated
- 20 December 2023
- Reason
- Firm discovered a firmware memory leak with a supplier-manufactured component.
- Distribution
- US Distribution to states of: NC and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1094-2022, Z-1093-2022
- Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
- NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Terminated Class II Medical devices
- Recall started
- 1 April 2022
- Terminated
- 10 July 2026
- Reason
- There is a potential for foreign matter.
- Distribution
- Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1019-2022
- Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow d
Ongoing Class II Medical devices
- Recall started
- 15 March 2022
- Reason
- This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0993-2022, Z-0992-2022, Z-0991-2022
- PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
- PrisMax System, Product Code 955724
- PrisMax System, Product Code 955626
Terminated Class II Medical devices
- Recall started
- 25 February 2022
- Terminated
- 15 May 2026
- Reason
- Devices distributed lacked regulatory clearance.
- Distribution
- US Nationwide distribution in the states of California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0831-2022
- MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Terminated Class II Medical devices
- Recall started
- 25 February 2022
- Terminated
- 2 March 2026
- Reason
- Product is mislabeled as self-righting Luer slip tip caps, yellow.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0948-2022
- Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Ongoing Class II Medical devices
- Recall started
- 21 February 2022
- Reason
- An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, ND, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. There was government distribution but no military distribution. The countries of Austria,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0829-2022
- Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
Terminated Class II Medical devices
- Recall started
- 14 February 2022
- Terminated
- 2 July 2026
- Reason
- Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, P
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0821-2022, Z-0820-2022
- Compella Therapy Air Supply Unit
- Compella Bariatric Bed System
Ongoing Class II Medical devices
- Recall started
- 7 January 2022
- Reason
- Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0576-2022, Z-0572-2022, Z-0570-2022, Z-0574-2022, Z-0578-2022, Z-0580-2022, Z-0579-2022, Z-0573-2022, Z-0577-2022, Z-0571-2022, Z-0575-2022
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
- Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
- Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
- Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
- Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
- and 3 more product lines
Ongoing Class I Medical devices
- Recall started
- 29 December 2021
- Reason
- There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
- Distribution
- Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0529-2022, Z-0530-2022
- Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Ongoing Class II Medical devices
- Recall started
- 29 September 2021
- Reason
- If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
- Distribution
- Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finl
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0215-2022
- Hemodialysis Delivery System, Software Version 2.x.
Terminated Class II Medical devices
- Recall started
- 22 July 2021
- Terminated
- 17 January 2024
- Reason
- Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2379-2021, Z-2378-2021
- Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
- Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 9555
Terminated Class I Medical devices
- Recall started
- 7 July 2021
- Terminated
- 20 June 2024
- Reason
- Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2165-2021
- Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Terminated Class II Medical devices
- Recall started
- 30 June 2021
- Terminated
- 10 April 2024
- Reason
- Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2173-2021, Z-2174-2021
- Sharesource Connectivity Platform for Use with the Amia Automated PD System
- Kaguya Automated Peritoneal Dialysis System
Terminated Class II Medical devices
- Recall started
- 15 June 2021
- Terminated
- 12 January 2024
- Reason
- There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
- Distribution
- United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2051-2021
- EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Terminated Class I Medical devices
- Recall started
- 4 June 2021
- Terminated
- 25 September 2024
- Reason
- System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
- Distribution
- United States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2110-2021
- Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Terminated Class II Medical devices
- Recall started
- 14 April 2021
- Terminated
- 10 May 2024
- Reason
- There is a potential leak between the venous patient connector and patient's hemodialysis access.
- Distribution
- Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1684-2021
- Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Terminated Class II Medical devices
- Recall started
- 19 March 2021
- Terminated
- 15 July 2022
- Reason
- Potentially defective component in the AC power adapter which may fail over time.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, FL, IA, IN, LA, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NY, OH, PA, RI, SC, TN, TX and the country of Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1487-2021
- Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
Terminated Class II Medical devices
- Recall started
- 28 January 2021
- Terminated
- 13 June 2024
- Reason
- Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
- Distribution
- Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1278-2021, Z-1279-2021, Z-1280-2021, Z-1277-2021
- Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
- Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
- Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
- Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Terminated Class II Medical devices
- Recall started
- 7 January 2021
- Terminated
- 30 April 2024
- Reason
- Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Fin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1151-2021
- The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Prod
Terminated Class II Medical devices
- Recall started
- 6 January 2021
- Terminated
- 4 May 2026
- Reason
- Battery performance issues related to prolonged storage.
- Distribution
- Domestic Distribution: ST, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico. International Distribution: Canada, Barbados, Bermu
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1150-2021
Ongoing Class II Medical devices
- Recall started
- 30 December 2020
- Reason
- complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1121-2021, Z-1120-2021, Z-1118-2021, Z-1122-2021, Z-1123-2021, Z-1119-2021
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Syste
- Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Ongoing Class II Medical devices
- Recall started
- 28 December 2020
- Reason
- Potential for the battery to lose its ability to be recharged.
- Distribution
- Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0939-2021
- FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Terminated Class II Medical devices
- Recall started
- 21 December 2020
- Terminated
- 11 July 2024
- Reason
- There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1102-2021
- Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular a
Terminated Class II Medical devices
- Recall started
- 11 December 2020
- Terminated
- 24 March 2023
- Reason
- VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL, IL, MA, MS, OH, OR, TX, VA, WA, WV and the countries of Australia, Poland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0807-2021
- VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
Ongoing Class II Medical devices
- Recall started
- 23 November 2020
- Reason
- There is a potential software error during programming.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0712-2021, Z-0714-2021, Z-0715-2021, Z-0713-2021
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Terminated Class II Medical devices
- Recall started
- 10 November 2020
- Terminated
- 24 March 2023
- Reason
- Potential for no-flow and leaks under the twist clamp.
- Distribution
- Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0768-2021
- MiniCap Extended Life PD Transfer Set
Terminated Class II Drugs
- Recall started
- 7 October 2020
- Terminated
- 22 May 2023
- Reason
- Presence of particulate matter in solution - black and transparent particles
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0076-2021
- Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxte
Terminated Class I Medical devices
- Recall started
- 30 June 2020
- Terminated
- 29 April 2024
- Reason
- Baxter is updating the device IFU for safety communication regarding cleaning practices.
- Distribution
- Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0121-2021, Z-0122-2021, Z-0123-2021, Z-0120-2021
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Spectrum IQ Infusion System with Dose IQ Safety Software
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Ongoing Class II Medical devices
- Recall started
- 2 June 2020
- Reason
- A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
- Distribution
- U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2474-2020
- Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Terminated Class II Medical devices
- Recall started
- 17 April 2020
- Terminated
- 7 February 2023
- Reason
- Potential disconnection of tubing set.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Countries of Australia, Austria, Bahrain, B
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2196-2020, Z-2193-2020, Z-2194-2020, Z-2195-2020
- Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
- Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Terminated Class II Medical devices
- Recall started
- 7 April 2020
- Terminated
- 9 November 2021
- Reason
- Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
- Distribution
- Distribution only to Puerto Rico and Guam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2066-2020
Terminated Class II Medical devices
- Recall started
- 5 March 2020
- Terminated
- 2 August 2021
- Reason
- The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
- Distribution
- Worldwide distribution - United States Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI and countries of Saudi Arabia, Italy, Austria, Argentina, Japan, Israel,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1686-2020, Z-1687-2020, Z-1685-2020
- GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
- GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
- GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
Terminated Class II Medical devices
- Recall started
- 6 February 2020
- Terminated
- 1 June 2021
- Reason
- Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Distribution
- Distribution in US, Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1830-2020, Z-1831-2020, Z-1832-2020, Z-1828-2020, Z-1829-2020, Z-1833-2020
- Prismaflex System, Prismaflex Control Unit
- Prismaflex System, Prismaflex Control Unit
- Prismaflex System, Prismaflex Control Unit
- Prismaflex System, Prismaflex Control Unit
- Prismaflex System, Prismaflex Control Unit
- Prismaflex System, Prismaflex Control Unit
Ongoing Class II Medical devices
- Recall started
- 12 December 2019
- Reason
- Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana and Barbados, Mexico, Canada, and New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0793-2020, Z-0794-2020
- Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access d
- ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient
Terminated Class II Drugs
- Recall started
- 19 November 2019
- Terminated
- 4 February 2021
- Reason
- Lack of Assurance of Sterility: Product has the potential to leak.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0517-2020
- 0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Terminated Class II Medical devices
- Recall started
- 15 November 2019
- Terminated
- 20 November 2020
- Reason
- There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1409-2020
- Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Ongoing Class II Medical devices
- Recall started
- 4 October 2019
- Reason
- Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0276-2020, Z-0277-2020, Z-0279-2020, Z-0280-2020, Z-0278-2020
- Prismaflex Control Unit, software versions below 7.21
- Prismaflex Control Unit, software versions below 7.21
- Prismaflex Control Unit, software versions below 7.21
- Prismaflex Control Unit, software versions below 7.21
- Prismaflex Control Unit, software versions below 7.21
Terminated Class II Medical devices
- Recall started
- 19 September 2019
- Terminated
- 11 December 2020
- Reason
- TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
- Distribution
- Nationwide distribution to Georgia and Maryland. International distribution to Belgium, Germany, Finland, France, Greece, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, Australia, and New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0247-2020
- TherMax Blood Warmer Unit
Terminated Class II Medical devices
- Recall started
- 18 September 2019
- Terminated
- 16 February 2021
- Reason
- Potential ability to leak once used for compounding.
- Distribution
- Worldwide distribution - UD Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of Canada, Aust
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0167-2020
- EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Pro
Terminated Class III Medical devices
- Recall started
- 13 August 2019
- Terminated
- 23 November 2020
- Reason
- Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers.
- Distribution
- Worldwide distribution - including US Nationwide distribution, and country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0050-2020
- EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for
Terminated Class II Drugs
- Recall started
- 18 July 2019
- Terminated
- 19 April 2021
- Reason
- Lack of Assurance of Sterility: Bags have potential to leak.
- Distribution
- Nationwide in the United States and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1514-2019
- 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Terminated Class III Medical devices
- Recall started
- 27 June 2019
- Terminated
- 2 November 2020
- Reason
- EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2432-2019
- EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
Terminated Class II Drugs
- Recall started
- 13 June 2019
- Terminated
- 29 April 2020
- Reason
- Failed Stability Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1435-2019
- Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Terminated Class II Medical devices
- Recall started
- 31 May 2019
- Terminated
- 5 October 2020
- Reason
- There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
- Distribution
- US Nationwide Distribution and Internationally to: Canada and Bermuda.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1909-2019, Z-1908-2019
- REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
- REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Terminated Class II Drugs
- Recall started
- 2 January 2019
- Terminated
- 29 April 2020
- Reason
- Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
- Distribution
- Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0351-2019
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Terminated Class II Medical devices
- Recall started
- 11 December 2018
- Terminated
- 12 February 2021
- Reason
- Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
- Distribution
- Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canad
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0850-2019, Z-0849-2019
- Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
- AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Ongoing Class II Medical devices
- Recall started
- 2 November 2018
- Reason
- Potential presence of rust on Coupler Forceps (GEM4183C).
- Distribution
- Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0680-2019
- GEM Coupler Forceps, GEM4183C, packaged individually.
Terminated Class III Drugs
- Recall started
- 15 October 2018
- Terminated
- 12 August 2022
- Reason
- Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
- Distribution
- Distributed nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0222-2019
- Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, I
Terminated Class II Medical devices
- Recall started
- 10 October 2018
- Terminated
- 22 July 2020
- Reason
- Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis.
- Distribution
- U.S.: VA, DC, CA, FL, SC, MD, DE, PA, NC, WA, GA, TX, NV. No foreign (OUS) distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0030-2020
- L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Terminated Class III Drugs
- Recall started
- 25 September 2018
- Terminated
- 26 June 2020
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1215-2018
- Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., Nor
Terminated Class II Medical devices
- Recall started
- 18 September 2018
- Terminated
- 19 August 2020
- Reason
- If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
- Distribution
- NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0107-2019
- SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Terminated Class II Medical devices
- Recall started
- 12 September 2018
- Terminated
- 2 November 2020
- Reason
- Potential ability to leak once used for compounding.
- Distribution
- Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zeal
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0363-2019, Z-0367-2019, Z-0365-2019, Z-0366-2019, Z-0364-2019
- EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
- EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
- EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
- EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
- EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Terminated Class II Drugs
- Recall started
- 6 September 2018
- Terminated
- 1 October 2020
- Reason
- cGMP Deviation
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1190-2018
- 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Terminated Class II Drugs
- Recall started
- 21 August 2018
- Terminated
- 30 October 2019
- Reason
- CGMP Deviations
- Distribution
- TX and MS only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1128-2018
- 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Terminated Class III Drugs
- Recall started
- 1 August 2018
- Terminated
- 16 July 2020
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Distribution
- Nationwide USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1034-2018, D-1036-2018, D-1035-2018
- Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables
- Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectabl
- Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectabl
Terminated Class II Medical devices
- Recall started
- 12 July 2018
- Terminated
- 31 March 2021
- Reason
- There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.
- Distribution
- US and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2597-2018
- power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
Terminated Class II Medical devices
- Recall started
- 21 June 2018
- Terminated
- 23 May 2019
- Reason
- The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, FA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1248-2019
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled
Ongoing Class II Medical devices
- Recall started
- 30 May 2018
- Reason
- Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.
- Distribution
- Nationwide distribution to AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Australia, Korea, Taiwan, Columbia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2957-2018
- FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATO
Terminated Class II Medical devices
- Recall started
- 8 May 2018
- Terminated
- 8 April 2019
- Reason
- The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
- Distribution
- Worldwide Distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2113-2018, Z-2112-2018
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the contro
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used fo
Terminated Class II Medical devices
- Recall started
- 25 April 2018
- Terminated
- 16 December 2020
- Reason
- Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
- Distribution
- Worldwide Distribution - US Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1909-2018, Z-1908-2018, Z-1910-2018, Z-1911-2018
- Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple
- Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compou
- Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple
- Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingre
Terminated Class II Medical devices
- Recall started
- 24 April 2018
- Terminated
- 22 June 2021
- Reason
- Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
- Distribution
- Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominic
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1926-2018, Z-1922-2018, Z-1925-2018, Z-1924-2018, Z-1923-2018
- Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and
- Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/
- Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and
- Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure an
- Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and
Terminated Class II Medical devices
- Recall started
- 3 April 2018
- Terminated
- 14 February 2020
- Reason
- Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
- Distribution
- US Nationwide & Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1665-2018, Z-1667-2018, Z-1663-2018, Z-1664-2018, Z-1666-2018
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administrat
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administra
- Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administrati
- Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administrat
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administra
Terminated Class II Medical devices
- Recall started
- 6 February 2018
- Terminated
- 2 April 2021
- Reason
- Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
- Distribution
- Distributed domestically to IL, MA, MD, OH, SD, TX, VA, WI. Distributed internationally to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0806-2018
- Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Terminated Class II Medical devices
- Recall started
- 21 December 2017
- Terminated
- 4 August 2020
- Reason
- Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was caused by an inadequate adhesive connection of the tubing to the Hansen connector of the MARS Tube Set which is part of the MARS Treatment Kit.
- Distribution
- US, Germany, Sweden, Italy, Belgium, Portugal, Spain, France, Russia, Poland, Turkey, China, Thailand, Taiwan, Hong Kong, Malaysia, Korea, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0411-2018
- MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
Terminated Class I Drugs
- Recall started
- 10 November 2017
- Terminated
- 29 August 2018
- Reason
- Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
- Distribution
- Nationwide within USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0573-2018
- Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Terminated Class II Medical devices
- Recall started
- 6 October 2017
- Terminated
- 11 April 2019
- Reason
- Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
- Distribution
- Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0971-2018
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Terminated Class II Medical devices
- Recall started
- 27 July 2017
- Terminated
- 3 November 2020
- Reason
- A leak may allow for microbial contamination of the sterile fluid path.
- Distribution
- Distribution in the US and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0485-2018
- Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Terminated Class II Medical devices
- Recall started
- 15 February 2017
- Terminated
- 8 May 2019
- Reason
- Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hu
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1280-2018
- Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or flu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.