BEUDAMED
    FDA Enforcement Class II Ongoing

    (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 · Reported February 19, 2025

    Enforcement

    Recall Number
    Z-1119-2025
    Event ID
    96055
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2025
    Initiation Date
    January 8, 2025
    Classification Date
    February 7, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    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

    Code Info

    (1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected

    Distribution

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

    Quantity

    137,741 total