BEUDAMED
    FDA Enforcement Class I Terminated

    RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.

    Recall: Z-0773-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0773-2023
    Event ID
    91336
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Emergent Protective Products USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2023
    Initiation Date
    November 24, 2022
    Classification Date
    January 10, 2023
    Termination Date
    October 7, 2024
    Address
    46 Shelby Thames Dr, Hattiesburg, MS, 39402-3702, United States

    Description

    RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.

    Reason

    Complaints of leaking packets were received.

    Code Info

    UDI-DI: 00817129020013, Lot numbers: 23005060, 23005061, 23005062. (01)00817129020013 (10) 23005060 (17) 270718 (F5408ENG)

    Distribution

    Distribution to US state of VA (distributor), Canada, and Switzerland

    Quantity

    4000 units