Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | 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). |
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| Recall Number | Z-0838-2013 |
| Classification | Class II |
| Code Info | Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106. |
| Product Distributed Qty | 469,134 units |
| 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. |
Event Detail
| Event Id | 64246 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Ansell Healthcare Products LLC |
| City | Iselin |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-14 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | .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. |
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