BEUDAMED
    FDA Enforcement Class II Ongoing

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    Recall: Z-0246-2022 · Reported December 8, 2021

    Enforcement

    Recall Number
    Z-0246-2022
    Event ID
    89050
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MAX LUX CORP
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    December 8, 2021
    Initiation Date
    October 26, 2021
    Classification Date
    November 29, 2021
    Address
    03e 01 01 Yangxi Indust, Ry Zone, Yangjiangyangjiang, N/A, China

    Description

    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

    Reason

    Excessive ultraviolet-C radiation

    Code Info

    Safe-T Lite

    Distribution

    US Nationwide Distribution

    Quantity

    9900 units