BEUDAMED
    FDA Enforcement Class II Ongoing

    IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.

    Recall: Z-1532-2025 · Reported April 16, 2025

    Enforcement

    Recall Number
    Z-1532-2025
    Event ID
    96422
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Omnicell, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 16, 2025
    Initiation Date
    February 20, 2025
    Classification Date
    April 4, 2025
    Address
    500 Cranberry Woods Dr Ste 400, N/A, Cranberry Township, PA, 16066-5224, United States

    Description

    IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.

    Reason

    IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.

    Code Info

    Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.

    Distribution

    Distributed in the US to Alabama

    Quantity

    3