Recall Z-1119-2025 ยท BRY Cabinet, Table And Tray, Anesthesia
CareFusion 303, Inc.
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
| Date | Feb 7, 2025 (initiated Jan 8, 2025) |
| Status | Open, Classified |
| Reason | Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues |
| Root cause | Software design |
| Action | On January 8, 2025, the firm notified customers via email and mailed letter titled "Urgent Medical Device Correction". Firm states customers can continue to use Pyxis products in accordance with their labeling and any previously provided field action notifications, including the following guidance: 1. Facilities should establish policies and procedures for when an automated dispensing system is unavailable. 2. Device Keys can manually access unavailable drawers, but must be readily available and retrievable to adequately mitigate the risk. 3. Emergency supplies should be physically availab |
| Quantity | 137,741 total |
| Distribution | Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.