BEUDAMED
    FDA Recall Terminated

    CryoValve Allograft, Heart valve

    Recall: Z-0866-03 · Initiated April 30, 2003

    Recall

    Recall Number
    Z-0866-03
    Event Number
    26205
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2003
    Posted
    May 22, 2003
    Terminated
    April 29, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve Allograft, Heart valve

    Reason

    Microorganisms were detected in associated allografts.

    Action

    Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.

    Distribution

    The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.

    Quantity

    8 units