BEUDAMED
    FDA Enforcement Class II Terminated

    Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00

    Recall: Z-0994-2019 · Reported March 20, 2019

    Enforcement

    Recall Number
    Z-0994-2019
    Event ID
    81964
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Reckitt Benckiser LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2019
    Initiation Date
    December 19, 2018
    Classification Date
    March 8, 2019
    Termination Date
    March 26, 2021
    Address
    399 Interpace Pkwy, N/A, Parsippany, NJ, 07054-1133, United States

    Description

    Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00

    Reason

    Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

    Code Info

    WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

    Distribution

    Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

    Quantity

    34920