LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A shea
FDA device recall Z-0838-2013 · posted 2013-02-20 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Products LLC
- Reason for recall
- Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
- Action taken
- Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155. If you have further questions, please contact our Customer Service Department at 1-800-952-9916.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HIS
- Quantity affected
- 469,134 units
- Distribution
- .Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.
- Date initiated
- 2013-01-14
- Date posted
- 2013-02-20
- Date terminated
- 2015-08-06
- Location
- Iselin, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESTYLES ZERO LUBRICATED LATEX CONDOM (K120394) | Ansell Heathcare Products, LLC | 2012-05-08 |