BEUDAMED
    FDA Recall Terminated

    Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors

    Recall: Z-0401-03 · Initiated November 25, 2002

    Recall

    Recall Number
    Z-0401-03
    Event Number
    25095
    Firm
    Ansell Healthcare Inc
    FEI Number
    1019632
    Product Code
    HIS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2002
    Posted
    December 31, 2002
    Terminated
    October 15, 2003
    Address
    1500 Industrial Road, Dothan, AL, 36303

    Description

    Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors

    Reason

    The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards

    Action

    Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.

    Distribution

    Nationwide and Europe

    Quantity

    approximately 40 million condoms