Waltham, MA, United States
Fresenius Medical Care Holdings, Inc. recalls
44 recalls recorded since 2018, most recently on 12 May 2026. 32 are listed as ongoing. Status and classification are as published by the FDA.
Recalls44
Ongoing (FDA)32
Terminated or completed12
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 12 May 2026
- Reason
- Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
- Distribution
- US Nationwide distribution in the states of NY, TN and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2321-2026
- Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Ongoing Class II Medical devices
- Recall started
- 11 May 2026
- Reason
- Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, PA, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2702-2026
- 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Mod
Ongoing Class II Medical devices
- Recall started
- 7 May 2026
- Reason
- There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
- Distribution
- Domestic: TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2401-2026
- Bicarby Dialysate; Model number: RFP-400-G;
Ongoing Class II Drugs
- Recall started
- 6 April 2026
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0513-2026, D-0512-2026
- DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Stre
- DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Str
Ongoing Class II Medical devices
- Recall started
- 25 October 2025
- Reason
- Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
- Distribution
- Domestic: LA, MA, MN;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0936-2026
- 5008X CAREsystem +CLiC +CDX;
Ongoing Class II Medical devices
- Recall started
- 29 August 2025
- Reason
- To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0041-2026
- Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX
Ongoing Class II Drugs
- Recall started
- 27 May 2025
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0490-2025
- 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Ongoing Class II Medical devices
- Recall started
- 29 April 2025
- Reason
- Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1992-2025
- 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 500
Ongoing Class II Medical devices
- Recall started
- 5 December 2024
- Reason
- Potential for internal blood leaks due to cracked polyurethane
- Distribution
- Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0801-2025
Ongoing Class II Medical devices
- Recall started
- 8 August 2024
- Reason
- Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
- Distribution
- US Nationwide. Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3124-2024
- Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124
Ongoing Class II Drugs
- Recall started
- 18 June 2024
- Reason
- This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0608-2024
- DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitone
Ongoing Class II Medical devices
- Recall started
- 3 June 2024
- Reason
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Distribution
- Domestic: Nationwide Distribution. International: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2344-2024, Z-2347-2024, Z-2340-2024, Z-2343-2024, Z-2341-2024, Z-2346-2024, Z-2342-2024, Z-2345-2024
- RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Ongoing Class II Medical devices
- Recall started
- 16 May 2024
- Reason
- Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
- Distribution
- US Nationwide distribution in the states of AL, IN, AK, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2141-2024
- US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Ongoing Class II Medical devices
- Recall started
- 17 April 2024
- Reason
- An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1866-2024, Z-1868-2024, Z-1869-2024, Z-1867-2024, Z-1870-2024
- Blood Pump Rotor, Model Number: F40015481 Rev A
- 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- 2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Ongoing Class II Medical devices
- Recall started
- 8 April 2024
- Reason
- Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1822-2024
- Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchan
Ongoing Class I Medical devices
- Recall started
- 23 January 2024
- Reason
- The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Distribution
- Domestic: Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1324-2024, Z-1326-2024, Z-1327-2024, Z-1325-2024, Z-1323-2024
- stay-safe /Luer Lock Adapter 4 in
- stay-safe /Luer Lock Catheter Ext. 18 in
- stay-safe /Luer Catheter Ext. 6 in
- stay-safe /Luer Lock Catheter Ext. 12 in
- stay-safe /Safe Lock Catheter Ext. 12 in
Ongoing Class II Drugs
- Recall started
- 28 December 2023
- Reason
- Lack of Sterility Assurance
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0218-2024
- DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Ongoing Class III Medical devices
- Recall started
- 24 October 2023
- Reason
- Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0619-2024
- Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Ongoing Class II Medical devices
- Recall started
- 10 October 2023
- Reason
- Updating the labeling to include additional warnings and contraindications for potential side effects.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0507-2024
Ongoing Class I Medical devices
- Recall started
- 6 September 2023
- Reason
- Potential PCBA leaching from tubing of hemodialysis machines.
- Distribution
- Domestic: Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0034-2024, Z-0028-2024, Z-0035-2024, Z-0030-2024, Z-0031-2024, Z-0033-2024, Z-0029-2024, Z-0032-2024
- 2008T HD SYS. W/O CDX BLUESTAR
- 2008T Hemodialysis SYS, with CDX
- 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
- 2008T Hemodialysis System w/Bibag
- 2008T GEN 2 Bibag without CDX
- 2008T HD SYS. CDX W/BIBAG BLUESTAR
- 2008T Hemodialysis System without CDX
- 2008T HD SYS. CDX BLUESTAR
Ongoing Class I Medical devices
- Recall started
- 8 August 2023
- Reason
- There is a potential for blood backfill leakage and foreign material.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0007-2024, Z-0006-2024, Z-0005-2024
- 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
- 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
- 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Terminated Class II Drugs
- Recall started
- 23 May 2023
- Terminated
- 23 May 2024
- Reason
- Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
- Distribution
- Product was distributed to 32 clinics in SC, NC and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0777-2023
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Ongoing Class II Drugs
- Recall started
- 22 November 2022
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Distribution
- Product was distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0075-2023
- 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-
Ongoing Class II Drugs
- Recall started
- 11 October 2022
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0015-2023
- 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-
Ongoing Class II Medical devices
- Recall started
- 4 October 2022
- Reason
- The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
- Distribution
- Domestic distribution to AL AZ CA DC FL GA HI IL IN MD MI MO MS NE NJ NY OH PA SD TX VA No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0181-2023
- NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Ongoing Class II Medical devices
- Recall started
- 27 July 2022
- Reason
- (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0734-2023
- 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS S
Ongoing Class II Medical devices
- Recall started
- 21 June 2022
- Reason
- Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
- Distribution
- US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1769-2022, Z-1770-2022
- AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
- AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Ongoing Class II Medical devices
- Recall started
- 16 June 2022
- Reason
- Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1463-2022, Z-1464-2022
- AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
- AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Terminated Class II Medical devices
- Recall started
- 1 June 2022
- Terminated
- 7 October 2024
- Reason
- The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
- Distribution
- US Nationwide distribution in the states of Texas and Louisiana.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1311-2022
- NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Ongoing Class II Medical devices
- Recall started
- 31 May 2022
- Reason
- Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
- Distribution
- Natiowide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1371-2022, Z-1370-2022
- NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
- NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Terminated Class II Medical devices
- Recall started
- 4 May 2022
- Terminated
- 6 May 2024
- Reason
- Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
- Distribution
- US Nationwide distribution in the state of Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1303-2022
- Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Ongoing Class II Medical devices
- Recall started
- 7 December 2021
- Reason
- Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0562-2022
- Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas
Terminated Class II Medical devices
- Recall started
- 3 August 2021
- Terminated
- 10 April 2024
- Reason
- AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
- Distribution
- US Nationwide distribution in the states of NC and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1364-2022
- AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
Terminated Class II, Class III Drugs
- Recall started
- 28 April 2021
- Terminated
- 17 September 2021
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0603-2021, D-0606-2021, D-0609-2021, D-0605-2021, D-0608-2021, D-0610-2021, D-0607-2021, D-0604-2021
- Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
- DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
- DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
- DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius
- DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius M
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Wal
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92
- DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Terminated Class II Medical devices
- Recall started
- 28 April 2021
- Terminated
- 8 August 2022
- Reason
- Exposed to freezing temperatures due to refrigerated truck malfunctions
- Distribution
- US Distribution to: TX only
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2086-2021, Z-2082-2021, Z-2083-2021, Z-2084-2021, Z-2088-2021, Z-2085-2021, Z-2087-2021, Z-2089-2021, Z-2090-2021
- Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physi
- (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO &
- The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the eff
- Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s p
- The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses
- 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
- NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s pre
- The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 18 March 2021
- Terminated
- 10 April 2024
- Reason
- AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
- Distribution
- US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1536-2021
- AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis
Terminated Class II Medical devices
- Recall started
- 17 December 2020
- Terminated
- 5 January 2023
- Reason
- Bottles Missing Product Label
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0942-2021
- Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
Ongoing Class II Medical devices
- Recall started
- 23 November 2020
- Reason
- The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0832-2021, Z-0836-2021, Z-0838-2021, Z-0834-2021, Z-0839-2021, Z-0833-2021, Z-0841-2021, Z-0837-2021, Z-0831-2021, Z-0840-2021, Z-0835-2021
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- and 3 more product lines
Ongoing Class II Medical devices
- Recall started
- 7 November 2020
- Reason
- The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0823-2021, Z-0822-2021, Z-0824-2021, Z-0813-2021, Z-0817-2021, Z-0825-2021, Z-0812-2021, Z-0827-2021, Z-0811-2021, Z-0820-2021, Z-0814-2021, Z-0816-2021 and 7 more
- NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia
- and 11 more product lines
Completed Class II Medical devices
- Recall started
- 12 September 2020
- Reason
- The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
- Distribution
- Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0439-2021
- Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Terminated Class II Medical devices
- Recall started
- 1 September 2020
- Terminated
- 20 January 2021
- Reason
- Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
- Distribution
- US distribution to DE, NC, OK, PA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0098-2021
- AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies.
Ongoing Class II Medical devices
- Recall started
- 12 March 2020
- Reason
- A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
- Distribution
- Nationwide Foreign: Canada, Curaca, Guam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1748-2020, Z-1749-2020
- Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMO
- Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W
Terminated Class II Drugs
- Recall started
- 5 March 2020
- Terminated
- 3 February 2023
- Reason
- CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1064-2020
- Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Terminated Class II Medical devices
- Recall started
- 29 January 2020
- Terminated
- 6 January 2021
- Reason
- The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1529-2020
- Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home
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.