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Class 2 Device Recall MICROTOUCH(R), NITRILE, Powder Free, Medical Examination Gloves |
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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
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Product Classification |
examination gloves - Product Code LZC
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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
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Code Information |
11040192EP |
Recalling Firm/ Manufacturer |
Ansell Healthcare Products LLC 1635 Industrial Rd Dothan AL 36303-5750
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For Additional Information Contact |
Dorothea Klein 732-345-5400
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Manufacturer Reason for Recall |
Gloves were inadvertently released for distribution prior to completion of testing required by the U.S. Food and Drug Administration.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LZC and Original Applicant = PERUSAHAAN GETAH ASAS SDN BHD
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