—#211880

Product

(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

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: (1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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 available in care areas for critical or urgent medications. 4. If using critical override mode to access contents of the device, users must use extra precautions and verify correct medications are selected. The firm anticipates releasing software update ES 1.11 beginning June 2025, which will address these software issues.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.

Timeline

Recall initiated: 2025-01-08
Posted by FDA: 2025-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.