Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Zero		see related information
Date Posted February 20, 2013
Recall Number Z-0838-2013
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
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 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.
 
-
-