BEUDAMED
    FDA Recall Terminated

    MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia

    Recall: Z-3114-2011 · Initiated August 4, 2011

    Recall

    Recall Number
    Z-3114-2011
    Event Number
    59777
    Firm
    Ansell Healthcare Products LLC
    FEI Number
    1019632
    Product Code
    LZC
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    August 4, 2011
    Posted
    August 31, 2011
    Terminated
    November 27, 2012
    Address
    1635 Industrial Rd, Dothan, AL, 36303-5750

    Description

    MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia

    Reason

    Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.

    Action

    Ansell account managers were notified on August 4, 2011 to contact (by phone, fax, e-mail) their respective accounts and notify them of the recall situation. The Ansell account managers were provided with a copy of the recall notification to provide to their accounts. The recall notification includes a request that if these gloves have been further distributed to other customers, please advise them of the recall situation and have them return any outstanding stocks.

    Distribution

    Nationwide distribution: NC, GA, IL, MO, LA, and PA

    Quantity

    370 cases of 10