BEUDAMED
    FDA Recall Open, Classified

    (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

    Recall: Z-1119-2025 · Initiated January 8, 2025

    Recall

    Recall Number
    Z-1119-2025
    Event Number
    96055
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    BRY
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 8, 2025
    Posted
    February 7, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    (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

    Reason

    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

    Action

    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.

    Distribution

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

    Quantity

    137,741 total