BEUDAMED
    FDA Recall Terminated

    CryoValve, Synegraft Pulmonary Valve & Conduit

    Recall: Z-1038-03 · Initiated July 10, 2003

    Recall

    Recall Number
    Z-1038-03
    Event Number
    26693
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 10, 2003
    Posted
    July 22, 2003
    Terminated
    May 12, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve, Synegraft Pulmonary Valve & Conduit

    Reason

    Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.

    Action

    The physician was notified by letter on 7/10/2003.

    Distribution

    The tissue was distributed to one physician in CA.

    Quantity

    1 tissue