BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve & Conduit

    Recall: Z-0026-05 · Initiated July 15, 2004

    Recall

    Recall Number
    Z-0026-05
    Event Number
    30191
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2004
    Posted
    October 20, 2004
    Terminated
    December 31, 2007
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Pulmonary Valve & Conduit

    Reason

    A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.

    Action

    The physician was notified by letter on 07/15/2004.

    Distribution

    The tissue was shipped to one physician in CA.

    Quantity

    1 tissue