BEUDAMED
    FDA Enforcement Class II Ongoing

    DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

    Recall: Z-1506-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1506-2023
    Event ID
    91987
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DermLite LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 10, 2023
    Initiation Date
    March 20, 2023
    Classification Date
    May 4, 2023
    Address
    31521 Rancho Viejo Rd Ste 104, San Juan Capistrano, CA, 92675-1868, United States

    Description

    DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

    Reason

    Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

    Code Info

    Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.

    Quantity

    32 units