BEUDAMED
    FDA Recall Terminated

    CryoValve Allograft, Heart valve.

    Recall: Z-0719-03 · Initiated February 24, 2003

    Recall

    Recall Number
    Z-0719-03
    Event Number
    25819
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2003
    Posted
    April 10, 2003
    Terminated
    July 23, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve Allograft, Heart valve.

    Reason

    Pre-processing cultures detected certain microorganisms in donor tissue.

    Action

    Consignees were first notified by telephone on 2/24/2003 with follow up letter on March 6, 2003 and were advised, if the tissue had not yet been implanted, to remove tissue from implantable inventory and place it into quarantine. CryoLife will provide specific instructions for returning the tissue. A stamped, self-addressed postcard was provided to confirm receipt of the notice and to provide information regarding the disposition of the tissue.

    Distribution

    Heart allografts were distributed to two hospitals in OH and Quebec, Canada.

    Quantity

    2 individual heart valve allografts.