BEUDAMED
    FDA Recall Terminated

    CryoValve, Aortic Valve and Conduit

    Recall: Z-0746-04 · Initiated February 18, 2004

    Recall

    Recall Number
    Z-0746-04
    Event Number
    28558
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 18, 2004
    Posted
    July 20, 2004
    Terminated
    March 30, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Aortic Valve and Conduit

    Reason

    CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.

    Action

    Consignees were notified by telephone on 02/18/2004.

    Distribution

    DC, TX

    Quantity

    1 unit