Vernon Hills, IL, United States
Carefusion 2200 Inc recalls
9 recalls recorded since 2018, most recently on 13 July 2023. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)5
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 July 2023
- Reason
- Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2421-2023, Z-2420-2023, Z-2428-2023, Z-2417-2023, Z-2418-2023, Z-2415-2023, Z-2422-2023, Z-2423-2023, Z-2427-2023, Z-2416-2023, Z-2424-2023, Z-2419-2023 and 3 more
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
- Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
- and 7 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 March 2023
- Reason
- A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
- Distribution
- Distribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WV, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1421-2023
- (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).
Ongoing Class II Medical devices
- Recall started
- 30 January 2023
- Reason
- Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
- Distribution
- Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Un
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1236-2023
- CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GEN
Ongoing Class II Medical devices
- Recall started
- 2 November 2022
- Reason
- BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer's IFU. This missing content is related to the interface with the device power supply, as well as cleaning and maintenance instructions. Refer to the attached V. Mueller" Bipolar Forcep IFU.
- Distribution
- Nationwide, Austria, Canada, Egypt, Germany, Hong Kong, Israel, Philippines, Saudi Arabia, South Africa, South Korea, Thailand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0391-2023, Z-0382-2023, Z-0377-2023, Z-0411-2023, Z-0415-2023, Z-0410-2023, Z-0393-2023, Z-0394-2023, Z-0397-2023, Z-0387-2023, Z-0404-2023, Z-0409-2023 and 33 more
- Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
- Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
- Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
- CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
- CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303
- CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126
- Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
- Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
- and 37 more product lines
Ongoing Class II Medical devices
- Recall started
- 26 September 2022
- Reason
- Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
- Distribution
- US and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, UK, United Arab Emirates
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0214-2023, Z-0211-2023, Z-0213-2023, Z-0210-2023, Z-0204-2023, Z-0217-2023, Z-0205-2023, Z-0203-2023, Z-0208-2023, Z-0209-2023, Z-0207-2023, Z-0219-2023 and 5 more
- CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
- CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
- CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
- CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
- CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
- CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
- CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
- CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 23 February 2022
- Terminated
- 2 May 2023
- Reason
- The finished device package did not contain the IFU.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, IN, LA, MA, MI, MN, MS, MT, NC, NY, OH, OK, PA, TN, TX, VA, and WI. The countries of Taiwan and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0833-2022
- (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920
Terminated Class II Medical devices
- Recall started
- 28 May 2020
- Terminated
- 20 September 2024
- Reason
- The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- Distribution
- 370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2659-2020, Z-2652-2020, Z-2656-2020, Z-2657-2020, Z-2649-2020, Z-2651-2020, Z-2647-2020, Z-2650-2020, Z-2654-2020, Z-2648-2020, Z-2653-2020, Z-2658-2020 and 2 more
- Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
- Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
- Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
- Thora-Para 5 Fr Catheter Drainage Tray
- Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
- Safe-T-Centesis 8 Fr Catheter Drainage Tray
- Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
- Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
- and 6 more product lines
Terminated Class II Medical devices
- Recall started
- 18 May 2020
- Terminated
- 25 April 2021
- Reason
- Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.
- Distribution
- US Nationwide distribution including in the states of CA, FL, VA and KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2400-2020
- Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.
Terminated Class II Medical devices
- Recall started
- 23 February 2017
- Terminated
- 9 July 2019
- Reason
- The integrity of the sterile packaging is potentially compromised.
- Distribution
- Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1422-2018, Z-1426-2018, Z-1425-2018, Z-1423-2018, Z-1424-2018, Z-1421-2018
- JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
- Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
- JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
- ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
- JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
- Manometer, 550 ml three-Way Stopcock; STERILE;
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.