BEUDAMED
    FDA Recall Open, Classified

    D&C pack

    Recall: Z-1704-2022 · Initiated June 16, 2022

    Recall

    Recall Number
    Z-1704-2022
    Event Number
    90574
    Firm
    American Contract Systems, Inc.
    FEI Number
    3003419114
    Product Code
    PKF
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    June 16, 2022
    Address
    2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648

    Description

    D&C pack

    Reason

    Product was exposed to multiple sterilization cycles without validation for multiple exposures.

    Action

    The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to [email protected] as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.

    Distribution

    Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

    Quantity

    1 unit