Recall Z-1550-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 155145-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P
| Date | Apr 9, 2025 (initiated Mar 11, 2025) |
| Status | Open, Classified |
| Reason | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients. |
| Root cause | Device Design |
| Action | On 03/11/2025, firm sent via FedEx 2-day mail and email an "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them of 3 failure scenarios associated with: -BD Pyxis MedBank CUBIE Replenishment (CR) Station -BD Pyxis MedBank Mini -BD Pyxis MedBank Tower -BD Pyxis MedFlex -BD Pyxis MedBank MedPass Where failure of these systems could result in inaccuracies or discrepancies in inventory management of medications. Customer are instructed to: 1.Best practice is to verify the total dose being removed is accurate against the provider s order, and if available utilize barcode medication |
| Quantity | 404 systems |
| Distribution | U.S.: AL,AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.