Recall Z-0838-2013 ยท HIS Condom
Ansell Healthcare Products LLC
LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
| Date | Feb 20, 2013 (initiated Jan 14, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120394 | LIFESTYLES ZERO LUBRICATED LATEX CONDOM Ansell Heathcare Products, LLC, May 8, 2012 |