BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve & Conduit

    Recall: Z-1589-05 · Initiated April 19, 2004

    Recall

    Recall Number
    Z-1589-05
    Event Number
    32841
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2004
    Posted
    September 28, 2005
    Terminated
    January 7, 2008
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Pulmonary Valve & Conduit

    Reason

    This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.

    Action

    Consignees were notified by telephone and letter on 04/19/2004.

    Distribution

    MO, TX and Sidney Australia

    Quantity

    1 tissue