BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve and Conduit

    Recall: Z-0684-05 · Initiated December 17, 2004

    Recall

    Recall Number
    Z-0684-05
    Event Number
    31140
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 17, 2004
    Posted
    April 6, 2005
    Terminated
    June 1, 2005
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Pulmonary Valve and Conduit

    Reason

    During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.

    Action

    Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.

    Distribution

    CA, NJ, TX

    Quantity

    1 tissue