BEUDAMED
    FDA Recall Terminated

    CryoValve, Aortic Valve & Conduit

    Recall: Z-0776-04 · Initiated February 20, 2004

    Recall

    Recall Number
    Z-0776-04
    Event Number
    28726
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 20, 2004
    Posted
    July 20, 2004
    Terminated
    February 10, 2005
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Aortic Valve & Conduit

    Reason

    Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.

    Action

    Consignee was notified first by telephone on 02/20/2004, then with follow up letter on 04/02/2004.

    Distribution

    This tissue was distributed to one physician in CA.

    Quantity

    1 unit