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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 Device Recall LifeStyles Pleasure Collection Condomssee related information
Date Initiated by FirmNovember 05, 2012
Date PostedJanuary 24, 2013
Recall Status1 Terminated 3 on July 31, 2013
Recall NumberZ-0717-2013
Recall Event ID 63873
510(K)NumberK000408 K941258 K983320 
Product Classification Condom - Product Code HIS
ProductLifestyles 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
FEI Number 1019632
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
1635 Industrial Rd
Dothan AL 36303-5750
For Additional Information Contact
800-722-8155
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		Packaging
ActionAnsell 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 Commerce445 cases (10680 consumer units)
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HIS
510(K)s with Product Code = HIS
510(K)s with Product Code = HIS
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