BEUDAMED
    FDA Recall Terminated

    CryoValve Pulmonary Valve and Conduit

    Recall: Z-0548-04 · Initiated December 10, 2003

    Recall

    Recall Number
    Z-0548-04
    Event Number
    28345
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 10, 2003
    Posted
    February 25, 2004
    Terminated
    July 23, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve Pulmonary Valve and Conduit

    Reason

    As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

    Action

    The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.

    Distribution

    The allograft was shipped to one physician in TX.

    Quantity

    1 unit