BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve and Conduit

    Recall: Z-0669-05 · Initiated January 12, 2005

    Recall

    Recall Number
    Z-0669-05
    Event Number
    30971
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2005
    Posted
    April 6, 2005
    Terminated
    April 12, 2005
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Pulmonary Valve and Conduit

    Reason

    During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.

    Action

    Consignee was notified by letter on 01/12/2005.

    Distribution

    KS

    Quantity

    1 tissue