BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve & Conduit SG

    Recall: Z-0019-04 · Initiated August 18, 2003

    Recall

    Recall Number
    Z-0019-04
    Event Number
    27051
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 18, 2003
    Posted
    October 15, 2003
    Terminated
    October 15, 2003
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    CryoValve, Pulmonary Valve & Conduit SG

    Reason

    The heart valve procurement exceeded the warm ischemic time criteria.

    Action

    The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003.

    Distribution

    Tissue was distributed to one physician in CA.

    Quantity

    1 unit