BEUDAMED
    FDA Recall Open, Classified

    Medtronic InterStim Ground Pad REF 041826

    Recall: Z-2365-2023 · Initiated July 6, 2023

    Recall

    Recall Number
    Z-2365-2023
    Event Number
    92701
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    EZW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 6, 2023
    Posted
    August 10, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic InterStim Ground Pad REF 041826

    Reason

    Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

    Action

    The consignee recall notification was sent out via mail on 07/06/2023. The letter instructs the consignee to return any affected product they may have, and to forward the notification to those who need to be aware within the organization or to any location which the devices have been transferred. Consignee also asked to complete and return a confirmation.

    Distribution

    International distribution to the country of Iran.

    Quantity

    360 packs (36 kits of 10 packs each)