BEUDAMED
    FDA Recall Terminated

    CryoValve, Aortic Valve and Conduit

    Recall: Z-0686-05 · Initiated December 2, 2004

    Recall

    Recall Number
    Z-0686-05
    Event Number
    31243
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2004
    Posted
    April 6, 2005
    Terminated
    June 28, 2010
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Aortic Valve and Conduit

    Reason

    An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.

    Action

    Consignee was notified by letter on 12/02/2004.

    Distribution

    TN

    Quantity

    1 tissue