BEUDAMED
    FDA Enforcement Class II Ongoing

    SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415

    Recall: Z-1530-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1530-2022
    Event ID
    90650
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Family Dollar Stores, Llc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 24, 2022
    Initiation Date
    June 23, 2022
    Classification Date
    August 17, 2022
    Address
    500 Volvo Pkwy, Chesapeake, VA, 23320-1604, United States

    Description

    SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICATED CONDOM 3CT, SKU 900794 SKYN ELITE NON LATEX CONDOM 12CT, SKU 903415

    Reason

    Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

    Code Info

    All product sold between May 1, 2022 - June 10, 2022.

    Distribution

    Product distributed to Family Dollar retail stores in US nationwide.

    Quantity

    2877 total