BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis MedBank MedPass Software, REF: 139088-01

    Recall: Z-2646-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2646-2023
    Event ID
    92967
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2023
    Initiation Date
    August 18, 2023
    Classification Date
    September 28, 2023
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis MedBank MedPass Software, REF: 139088-01

    Reason

    After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.

    Code Info

    UDI-DI: 10885403513817, Software versions prior to but not including v1.2.3.23

    Distribution

    US: FL, MI, KS

    Quantity

    37