BEUDAMED
    FDA Enforcement Class II Ongoing

    Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373

    Recall: Z-1617-2023 · Reported May 31, 2023

    Enforcement

    Recall Number
    Z-1617-2023
    Event ID
    92136
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OmniCell, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 31, 2023
    Initiation Date
    March 27, 2023
    Classification Date
    May 22, 2023
    Address
    51 Pennwood Pl Ste 400, N/A, Warrendale, PA, 15086-6506, United States

    Description

    Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373

    Reason

    IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling

    Code Info

    UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019

    Distribution

    AL, NY

    Quantity

    6 units