BEUDAMED
    FDA Recall Terminated

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    Recall: Z-2847-2011 · Initiated June 10, 2011

    Recall

    Recall Number
    Z-2847-2011
    Event Number
    59155
    Firm
    Ansell Healthcare Products LLC
    FEI Number
    1019632
    Product Code
    NPD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 10, 2011
    Posted
    July 18, 2011
    Terminated
    January 10, 2013
    Address
    1635 Industrial Rd, Dothan, AL, 36303-5750

    Description

    ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018490, Size 9, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves

    Reason

    Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.

    Action

    Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.

    Distribution

    Nationwide Distribution

    Quantity

    25074 pairs