BEUDAMED
    FDA Enforcement Class II Terminated

    Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

    Recall: Z-3241-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3241-2018
    Event ID
    80841
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Reckitt Benckiser LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    July 23, 2018
    Classification Date
    September 24, 2018
    Termination Date
    March 5, 2020
    Address
    399 Interpace Pkwy, Parsippany, NJ, 07054-1133, United States

    Description

    Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

    Reason

    The products failed the filed specification of 1.0kPa for Burst Pressure.

    Code Info

    Batch Numbers: 1000427177, 1000408620, 1000430764

    Distribution

    US Nationwide.

    Quantity

    487980 condoms