BEUDAMED
    FDA Recall Terminated

    Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285

    Recall: Z-0893-2017 · Initiated October 24, 2016

    Recall

    Recall Number
    Z-0893-2017
    Event Number
    75737
    Firm
    Ansell Healthcare Products LLC
    FEI Number
    3009964047
    Product Code
    KGO
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    October 24, 2016
    Terminated
    October 23, 2017
    Address
    111 Wood Ave S, Ste 210, Iselin, NJ, 08830-2700

    Description

    Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285

    Reason

    Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.

    Action

    Ansell Healthcare Products, LLC. sent an Urgent: Voluntary Surgical Glove Recall letter dated October 28, 2016, to all affected customers. The letter identified the problem the product and the action the customer needs to take. Please check your product stock at the warehouse and shelf level in order to advise us directly if any gloves having the recalled lot numbers are found. This information, along with your tracking number, must be communicated to our Customer Service Department by calling 1-800-952-9916, or by returning the attached Response Form to Ansell by fax at 1-800-722-8155, or via email [email protected] . Returned product will either be replaced or credited without delay. Your Ansell representative will be available to follow up with you regarding any concerns you may have.

    Distribution

    US Distribution to the states of : PA, FL, NJ, IL and MA.

    Quantity

    15 Cartons