BEUDAMED
    FDA Recall Terminated

    Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case

    Recall: Z-0644-03 · Initiated February 12, 2003

    Recall

    Recall Number
    Z-0644-03
    Event Number
    25572
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    GBX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 12, 2003
    Posted
    March 12, 2003
    Terminated
    August 12, 2003
    Address
    One Medline Place, Mundelein, IL, 60060

    Description

    Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case

    Reason

    Some of the kits labeled as latex free contain latex gloves which are properly labeled.

    Action

    Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.

    Distribution

    Nationwide and Canada

    Quantity

    753 cases