BEUDAMED
    FDA Recall Terminated

    CryoValve, Aortic Valve & Conduit

    Recall: Z-0530-04 · Initiated January 16, 2004

    Recall

    Recall Number
    Z-0530-04
    Event Number
    28176
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 16, 2004
    Posted
    July 20, 2004
    Terminated
    September 3, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Aortic Valve & Conduit

    Reason

    Microorganisms were detected in associated tissue.

    Action

    Consignees were notified by letter on 1/16/2004.

    Distribution

    CA, MI,OK

    Quantity

    1 unit