BEUDAMED
    FDA Recall Terminated

    Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia

    Recall: Z-0365-2007 · Initiated December 18, 2006

    Recall

    Recall Number
    Z-0365-2007
    Event Number
    37013
    Firm
    Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia
    FEI Number
    3012304897
    Product Code
    KGO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2006
    Posted
    January 25, 2007
    Terminated
    August 12, 2009

    Description

    Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia

    Reason

    Some of the packages labeled as latex-free actually contain latex gloves.

    Action

    Terang Nusa telephoned Medline Industries on 12/13/06 requesting them to retrieve the affected lot of size six gloves from their customers. Medline Industries notified their customers by letter dated 12/20/06, informing them of the possible latex gloves being labeled as the Neolon 2G Neoprene Surgical Gloves, and requesting them to inspect their inventories for the suspect size and lot of gloves. The accounts were instructed to complete the enclosed response questionnaire, indicating the amount of affected gloves found, and fax it back to Medline at 847-949-2643 to obtain a return goods authorization. Any questions were directed to Kathy Dunne at 847-359-1704.

    Distribution

    Worldwide including USA, Canada, and Panama

    Quantity

    43 cases