BEUDAMED
    FDA Enforcement Class II Terminated

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    Recall: Z-1884-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-1884-2018
    Event ID
    78975
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SANTA JOY ORNAMENT & GIFTWARE CO
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    November 21, 2017
    Classification Date
    June 1, 2018
    Termination Date
    October 27, 2020
    Address
    3rd Block Changtian Ind, Hengli Town, Dongguan City, N/A, N/A, China

    Description

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    Reason

    It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.

    Code Info

    Model No: EZ-Illuminations Galaxy , EZ-Illuminations Northern Lights

    Distribution

    USA (nationwide) distribution

    Quantity

    433,128