Recall Z-0717-2013 ยท HIS Condom
Ansell Healthcare Products LLC
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.
| Date | Jan 24, 2013 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn. |
| Root cause | 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 | 445 cases (10680 consumer units) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000408 | LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM Suretex Prophylactics , Ltd., Apr 19, 2000 |
| K941258 | LATEX CONDOM Suretex, Ltd., Dec 6, 1995 |
| K983320 | ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS Suretex Prophylactics (India) , Ltd., Dec 11, 1998 |