BEUDAMED
    FDA Recall Terminated

    CryoValve Allograft heart valve

    Recall: Z-0675-03 · Initiated January 23, 2003

    Recall

    Recall Number
    Z-0675-03
    Event Number
    25593
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 23, 2003
    Posted
    March 21, 2003
    Terminated
    March 22, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve Allograft heart valve

    Reason

    An allograft associated with this donor has been linked to an alleged infection.

    Action

    A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction

    Distribution

    The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.

    Quantity

    1 unit