BEUDAMED
    FDA Recall Open, Classified

    (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

    Recall: Z-1120-2025 · Initiated January 8, 2025

    Recall

    Recall Number
    Z-1120-2025
    Event Number
    96056
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    BRY
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    January 8, 2025
    Posted
    February 7, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    (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

    Reason

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

    Action

    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: [email protected], Fax: (312) 949-0229

    Distribution

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

    Quantity

    193067