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Recall Observatory FDA recall evidence

Device 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).

Z-0838-2013

January 14, 2013

Class II

Product summary

Firm
Ansell Healthcare Products LLC
Event
Event 64246
Status
Terminated
Classification
Class II
Quantity
469,134 units
Official record key
device-enforcement:Z-0838-2013

Official wording

Reason: 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.

Code information: Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.