BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

    Recall: Z-0906-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0906-2025
    Event ID
    96002
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    April 5, 2023
    Classification Date
    January 14, 2025
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

    Reason

    Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.

    Code Info

    Software v1.7.3. REF/UDI-DI: 323/10885403512667, 352/10885403512674

    Distribution

    US Nationwide distribution in the states of NY, NC, LA.

    Quantity

    622