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.
FDA Recall Z-0717-2013 · Posted 2013-01-24
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Recalling FirmAnsell Healthcare Products LLC
Recall StatusTerminated
Product CodeHIS
Date Initiated2012-11-05
Date Terminated2013-07-31
Product Quantity445 cases (10680 consumer units)
Reason for Recall
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K000408LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOMSuretex Prophylactics , Ltd. · 2000-04-19K983320ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORSSuretex Prophylactics (India) , Ltd. · 1998-12-11K941258LATEX CONDOMSuretex, Ltd. · 1995-12-06
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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