—#211882

Product

(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: (1)BD Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) BD Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; ALL serial numbers; software versions v1.10 and prior. (4) BD Pyxis MedStation 4000 Console, Catalog No. 309, All serial numbers and all software versions, UDI-DI: 10885403512636; (5) BD Pyxis MedStation 4000, Catalog No. 303, All serial numbers and all software versions, UDI-DI: 10885403512629 (HW), 10885403513787 (SW); (6) BD Pyxis Anesthesia System 4000, Catalog No. 338, All serial numbers and all software versions, UDI-DI: 10885403477829 (HW), 10885403513787 (SW)

Why it was recalled

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

Root cause (FDA determination)

Labeling design

Action the firm took

On January 8, 2025, the firm notified customers through an "Urgent Medical Device Correction" letter sent via email and mailed notices. In addition to explaining software issues affecting the device (covered in RES 96055), the letter also provided customers with a list of mitigations that address device downtime as a result of power failure, network failure, or hardware failure. The firm will be updating product labeling and product guides to further strengthen recommendations. On September 25, 2025, additional correction notices were distributed identifying additional affected devices. If you require further assistance contact the firm: Technical Support for technical questions: bd.com/self-service, 1-800-727-6102, Hours: 24 hours, 7 days a week; BD Recall Operations to return the customer response form: BDRC5@bd.com, Fax: (312) 949-0229

Recalling firm

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

Distribution

Distribution pattern: Domestic distribution nationwide US. 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 #211882. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.