Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Th
FDA device recall Z-0717-2013 · posted 2013-01-24 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Products LLC
- Reason for recall
- One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
- Action taken
- 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
- Status
- Terminated
- Product code
- HIS
- Quantity affected
- 445 cases (10680 consumer units)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-11-05
- Date posted
- 2013-01-24
- Date terminated
- 2013-07-31
- Location
- Dothan, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM (K000408) | Suretex Prophylactics , Ltd. | 2000-04-19 |
| ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS (K983320) | Suretex Prophylactics (India) , Ltd. | 1998-12-11 |
| LATEX CONDOM (K941258) | Suretex, Ltd. | 1995-12-06 |