BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

    Recall: Z-1909-2018 · Reported May 30, 2018

    Enforcement

    Recall Number
    Z-1909-2018
    Event ID
    79975
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 30, 2018
    Initiation Date
    April 25, 2018
    Classification Date
    May 22, 2018
    Termination Date
    December 16, 2020
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.

    Reason

    Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

    Code Info

    UDI: 00085412475790 Lot Numbers: 802279, 802280, 802281

    Distribution

    Worldwide Distribution - US Distribution

    Quantity

    59475 units