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U.S. Department of Health and Human Services

Class 2 Device Recall MICROTOUCH(R), NITRILE, Powder Free, Medical Examination Gloves

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  Class 2 Device Recall MICROTOUCH(R), NITRILE, Powder Free, Medical Examination Gloves see related information
Date Initiated by Firm August 04, 2011
Date Posted August 31, 2011
Recall Status1 Terminated 3 on November 27, 2012
Recall Number Z-3114-2011
Recall Event ID 59777
510(K)Number K032374  
Product Classification examination gloves - Product Code LZC
Product MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
Code Information 11040192EP
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
1635 Industrial Rd
Dothan AL 36303-5750
For Additional Information Contact Dorothea Klein
732-345-5400
Manufacturer Reason
for Recall		 Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
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.
Quantity in Commerce 370 cases of 10
Distribution Nationwide distribution: NC, GA, IL, MO, LA, and PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZC and Original Applicant = PERUSAHAAN GETAH ASAS SDN BHD
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