Recall Z-1050-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.
| Date | Jan 30, 2025 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| Reason | Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication. |
| Root cause | Device Design |
| Action | On 02/14/2023 and 01/09/2024, the firm sent an "Urgent Medical Product Advisory" letter to customers informing them that BD was made aware due to an increase in customer complaints for AUX Tower Door Latch assembly failures. The latch failure can leave the door in an open state, potentially causing inventory discrepancies (including billing), a delay in access to medication and/or diversion of medication. Customers were instructed: 1. May continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800 |
| Quantity | Initial: 27,666 Expansion: 5,923 = 33,589 systems |
| Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Germany and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.