BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1617-2023 · Initiated March 27, 2023

    Recall

    Recall Number
    Z-1617-2023
    Event Number
    92136
    Firm
    OmniCell, Inc.
    FEI Number
    3011278888
    Product Code
    NEP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 27, 2023
    Posted
    May 22, 2023
    Address
    51 Pennwood Pl, Ste 400, Warrendale, PA, 15086-6506

    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

    Action

    Omincell notified Customers via phone on 3/27/2023 and by Urgent Field Action: Mandatory Correction Of Product Labeling Ivx Station (Limited Release) Letter on 3/31/2023 via email. Letter states reason for recall, health risk and action to take: We will analyze specific devices at your Limited Release sites. Upon completion of our analysis updated labeling will be provided and will include the revised dose accuracy range.

    Distribution

    AL, NY

    Quantity

    6 units