BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve & Conduit

    Recall: Z-1297-03 · Initiated September 10, 2003

    Recall

    Recall Number
    Z-1297-03
    Event Number
    27280
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    NJK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 10, 2003
    Posted
    October 15, 2003
    Terminated
    May 6, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve, Pulmonary Valve & Conduit

    Reason

    Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.

    Action

    Consignees were notified by letter on 09/10/2003 and 09/12/2003.

    Distribution

    The tissues were distributed to one hospital in CA and one physician in MN.

    Quantity

    1 unit