BEUDAMED
    FDA Recall Terminated

    ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves

    Recall: Z-0621-2011 · Initiated September 3, 2010

    Recall

    Recall Number
    Z-0621-2011
    Event Number
    57269
    Firm
    Ansell Healthcare Products LLC
    FEI Number
    1019632
    Product Code
    KGO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 3, 2010
    Posted
    December 15, 2010
    Terminated
    November 28, 2011
    Address
    1635 Industrial Rd, Dothan, AL, 36303-5750

    Description

    ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka Intended use: Surgical Gloves

    Reason

    open package seams on sterile gloves

    Action

    The firm, Ansell, sent a letter dated September 3, 2010 to all customers. The letter described the product, problem and actions taken. An Ansell representatives will contact the customer to remove the gloves bearing the noted lot number from their facility; Ansell will ensure that the gloves removed will be replaced shortly with products from a different manufacturing batch and the recall was extended to the retail (hospital and clinic) level requesting that the product be returned. If you have any questions, contact US (334) 615-2563, international telephone 01.34.24.52.52 and email: [email protected].

    Distribution

    International distribution only: France and Germany

    Quantity

    4000 units