BEUDAMED
    FDA Recall Terminated

    CryoValve Allograft, Heart valve

    Recall: Z-0672-03 · Initiated February 4, 2003

    Recall

    Recall Number
    Z-0672-03
    Event Number
    25675
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 4, 2003
    Posted
    March 21, 2003
    Terminated
    July 16, 2003
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve Allograft, Heart valve

    Reason

    Microorganisms were detected in distributed allografts.

    Action

    CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.

    Distribution

    The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.

    Quantity

    2 units