BEUDAMED
    FDA Recall Terminated

    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

    Recall: Z-0860-03 · Initiated April 30, 2003

    Recall

    Recall Number
    Z-0860-03
    Event Number
    26196
    Firm
    Medegen Medical Products, LLC
    FEI Number
    1716847
    Product Code
    KCP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2003
    Posted
    May 22, 2003
    Terminated
    November 14, 2003
    Address
    11060 Irma Drive, Northglenn, CO, 80233

    Description

    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

    Reason

    Finished products were not sterilized.

    Action

    Medegen has notified all direct accounts by certified mail on 4/30/03.

    Distribution

    Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.