FDAFDA · Food and drugs·Recall number Z-0838-2013
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).
Published February 27, 2013 · Recall initiated: January 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ansell Healthcare Products LLC
- Distributor
- .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.
- Lot
- Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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