BEUDAMED
    FDA Recall Terminated

    CryoValve Allograft, Aortic Valve & Conduit

    Recall: Z-0988-03 · Initiated May 5, 2003

    Recall

    Recall Number
    Z-0988-03
    Event Number
    26319
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2003
    Posted
    July 10, 2003
    Terminated
    July 10, 2003
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve Allograft, Aortic Valve & Conduit

    Reason

    Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.

    Action

    The hospital was notified by letter on 5/05/2003.

    Distribution

    Unit was distributed to one hospital in CA.

    Quantity

    1 unit