BEUDAMED
    FDA Enforcement Class II Terminated

    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).

    Recall: Z-0838-2013 · Reported February 27, 2013

    Enforcement

    Recall Number
    Z-0838-2013
    Event ID
    64246
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ansell Healthcare Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2013
    Initiation Date
    January 14, 2013
    Classification Date
    February 20, 2013
    Termination Date
    August 6, 2015
    Address
    111 Wood Ave S, Suite 210, Iselin, NJ, 08830-2700, United States

    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

    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 Info

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

    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.

    Quantity

    469,134 units