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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 Condoms see related information
Date Initiated by Firm November 05, 2012
Date Posted January 24, 2013
Recall Status1 Terminated 3 on July 31, 2013
Recall Number Z-0717-2013
Recall Event ID 63873
510(K)Number K983320  K000408  K941258  
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 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
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 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 = 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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