BEUDAMED
    FDA Recall Terminated

    CADD Administration Sets, Model #21-7346-24

    Recall: Z-0148-2022 · Initiated July 14, 2020

    Recall

    Recall Number
    Z-0148-2022
    Event Number
    88730
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 14, 2020
    Terminated
    August 4, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    CADD Administration Sets, Model #21-7346-24

    Reason

    Product may have been manufactured with an air filter assembled in an incorrect orientation.

    Action

    The firm notified its consignees of the issue beginning on 07/14/2020. The firm requested the return of unused product. Distributors were directed to notify their customers. For questions contact Smiths Medical via email at [email protected].

    Distribution

    Canada

    Quantity

    371 units