BEUDAMED
    FDA Recall Terminated

    Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021

    Recall: Z-1131-04 · Initiated July 13, 2004

    Recall

    Recall Number
    Z-1131-04
    Event Number
    29554
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    BYD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 13, 2004
    Posted
    July 22, 2004
    Terminated
    May 8, 2012
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021

    Reason

    Sterility of the device is compromised due to lack of package integrity

    Action

    Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product.

    Distribution

    Nationwide