BEUDAMED
    FDA Recall Terminated

    CryoValve Aortic Valve

    Recall: Z-0854-04 · Initiated February 25, 2004

    Recall

    Recall Number
    Z-0854-04
    Event Number
    28467
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 25, 2004
    Posted
    July 20, 2004
    Terminated
    September 14, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve Aortic Valve

    Reason

    A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.

    Action

    Consignees were notified by letter on 03/02/2004.

    Distribution

    CA

    Quantity

    1 unit