BEUDAMED
    FDA Recall Terminated

    CryoValve Pulmonary Valve & Conduct

    Recall: Z-0167-04 · Initiated November 4, 2003

    Recall

    Recall Number
    Z-0167-04
    Event Number
    27664
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 4, 2003
    Posted
    November 27, 2003
    Terminated
    May 6, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve Pulmonary Valve & Conduct

    Reason

    CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.

    Action

    Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.

    Distribution

    The tissue was shipped to one hospital in MO.

    Quantity

    One unit