BEUDAMED
    FDA Recall Terminated

    Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 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-1911-2018 · Initiated April 25, 2018

    Recall

    Recall Number
    Z-1911-2018
    Event Number
    79975
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    April 25, 2018
    Terminated
    December 16, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 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,

    Action

    The firm initiated the recall by letter on 04/25/2018. The letter identified the affected product, problem and actions to be taken. the firm requested the return of the product. Distributors were directed to conduct a sub-recall, requesting their customers return the product to the entity from whom they received the product.

    Distribution

    Worldwide Distribution - US Distribution

    Quantity

    112975 units