Recall Z-0838-2013— Ansell Healthcare Products LLC

Name: FDA recall Z-0838-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-14

Class II · Terminated

Class II FDA medical device recall by Ansell Healthcare Products LLC, initiated 2013-01-14, terminated 2015-08-06. It names one FDA 510(k) clearance: K120394. 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).. 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..

Recalling firm: Ansell Healthcare Products LLC
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Terminated: 2015-08-06
Firm location: Iselin, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K120394 — LIFESTYLES ZERO LUBRICATED LATEX CONDOMAnsell Heathcare Products, LLC·cleared 2012-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.