Recall Z-0671-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
| Date | Dec 11, 2024 (initiated Nov 14, 2024) |
| Status | Open, Classified |
| Reason | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout. |
| Root cause | Software design |
| Action | On 11/14/24, correction notices were mailed/emailed to customers: Devices can continue to be used in accordance with the following: Best practice is for providers (e.g., nurses) to verify the medication being removed is accurate against the hospital patient record (source of truth) prior to administration1. o Labeling includes the following warning: Always utilize the BD Pyxis ES System patient/order information in conjunction with the medical record when making clinical decisions. Making clinical decisions solely from System information may result in errors in care resulting in serious injury |
| Quantity | 40,763 |
| Distribution | Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries o |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.