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U.S. Department of Health and Human Services

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).
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.