BEUDAMED
    FDA Recall Terminated

    CryoValve Pulmonary Valve & Conduit.

    Recall: Z-0938-03 · Initiated May 23, 2003

    Recall

    Recall Number
    Z-0938-03
    Event Number
    26422
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2003
    Posted
    June 17, 2003
    Terminated
    December 10, 2003
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve Pulmonary Valve & Conduit.

    Reason

    Microorganisms detected in associated allografts.

    Action

    The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.

    Distribution

    The tissues were distributed to one medical facility in CT and to one physician in MT.

    Quantity

    2 individual heart valve allografts.