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U.S. Department of Health and Human Services

Class 2 Device Recall Zero

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 Class 2 Recall
Zero
see related information
Date Posted February 20, 2013
Recall Status1 Open
Recall Number Z-0838-2013
Recall Event ID 64246
Premarket Notification
510(K) Number
K120394 
Product Classification Condom - Product Code HIS
Product 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).
Code Information Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.
Recalling Firm/
Manufacturer
Ansell Healthcare Products LLC
111 Wood Ave S
Suite 210
Iselin, New Jersey 08830-2700
Consumer Instructions No consumer action necessary
For Additional Information Contact Robert S. Mahler
732-345-2174
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HIS and Original Applicant = ANSELL HEATHCARE PRODUCTS LLC
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