(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta

FDA device recall Z-1120-2025 · posted 2025-02-07 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

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

Action taken

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

Root cause

Labeling design

Status

Open, Classified

Product code

BRY

Quantity affected

193067

Distribution

Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.

Date initiated

2025-01-08

Date posted

2025-02-07

Location

San Diego, CA