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U.S. Department of Health and Human Services

Class 2 Device Recall LifeStyles Pleasure Collection Condoms

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 Class 2 Recall
LifeStyles Pleasure Collection Condoms
see related information
Date Posted January 24, 2013
Recall Status1 Terminated on July 31, 2013
Recall Number Z-0717-2013
Recall Event ID 63873
Premarket Notification
510(K) Numbers
K000408  K941258  K983320 
Product Classification Condom - Product Code HIS
Product Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.
Code Information Lot Code: 120921021C
Recalling Firm/
Manufacturer
Ansell Healthcare Products LLC
1635 Industrial Rd
Dothan, Alabama 36303-5750
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Ansell Healthcare Products LLC sent an "URGENT: VOLUNTARY CONDOM RECALL" letter/return response form dated November 5, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm's Customer Service Department at 1-800-305-1054 for questions or if additional information is needed.
Quantity in Commerce 445 cases (10680 consumer units)
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HIS and Original Applicant = SURETEX PROPHYLACTICS (INDIA) LTD.
510(K)s with Product Code = HIS and Original Applicant = SURETEX PROPHYLACTICS LTD.
510(K)s with Product Code = HIS and Original Applicant = SURETEX, LTD.
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