(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
- Company
- Carefusion 303, Inc.
- Recall Initiated
- January 8, 2025
- Posted
- February 7, 2025
- Recall Number
- Z-1120-2025
- Quantity
- 193067
- Firm Location
- San Diego, CA
Reason for Recall
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Distribution
Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
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)
Root Cause
Labeling design
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