BEUDAMED
    FDA Recall Terminated

    Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia

    Recall: Z-1185-06 · Initiated May 23, 2006

    Recall

    Recall Number
    Z-1185-06
    Event Number
    35609
    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
    May 23, 2006
    Posted
    June 27, 2006
    Terminated
    January 22, 2007

    Description

    Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia

    Reason

    The sterile glove pouches may have an open seal at the bottom of the pouch.

    Action

    Terang Nusa notified Medline Industries via letters dated 5/23/06 and 5/26/06 to cease distribution of the gloves due to the defective seals on the pouches, and retrieve the affected lot of size seven gloves from their customers. Medline Industries notified their customers by letter dated 6/1/06, informing them of the possible open seals on the packages of surgeon''s 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 847-970-4678.

    Distribution

    Nationwide

    Quantity

    51 cartons