BEUDAMED
    FDA Recall Open, Classified

    American Contract Systems Biopsy Drape Pack convenience kit

    Recall: Z-2523-2024 · Initiated May 6, 2024

    Recall

    Recall Number
    Z-2523-2024
    Event Number
    94908
    Firm
    American Contract Systems, Inc.
    FEI Number
    3003419114
    Product Code
    FCH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 6, 2024
    Posted
    August 7, 2024
    Address
    2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648

    Description

    American Contract Systems Biopsy Drape Pack convenience kit

    Reason

    Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

    Action

    The recalling firm issued recall letters on and dated 5/6/2024 via email or overnight mail. The letter explained the event details, product involved, risk to health, and actions to take. The actions included (1) review your inventory and segregate and quarantine all affected trays. If any of the trays have been further distributed, ensure all end users are notified and maintain records of effectiveness; (2) discard all affected kits and document on the enclosed Response Form; and (3) complete the enclosed Response Form and return it as soon as possible.

    Distribution

    US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

    Quantity

    224