BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis Med 4000 Auxiliary (AUX), REF 314

    Recall: Z-0976-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0976-2025
    Event ID
    96053
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    February 14, 2023
    Classification Date
    January 17, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis Med 4000 Auxiliary (AUX), REF 314

    Reason

    Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

    Code Info

    UDI/DI 10885403512650, Serial Numbers: 16140589, 16194078, 16194079, 16194081, 16079165.

    Distribution

    Worldwide

    Quantity

    5 units