BEUDAMED
    FDA Recall Terminated

    Ultra Renew Plus

    Recall: Z-0821-2018 · Initiated December 4, 2017

    Recall

    Recall Number
    Z-0821-2018
    Event Number
    79262
    Firm
    Accord Media, LLC Apartment
    FEI Number
    3011053331
    Product Code
    OLP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 4, 2017
    Terminated
    May 28, 2020
    Address
    241 West 36th Street, 16, New York, NY, 10018

    Description

    Ultra Renew Plus

    Reason

    Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation

    Action

    On December 4, 2017, Accord Media distributed Urgent Medical Device Field Action notices and Response Forms to customers via courier service. Customers were instructed to inspect stock and identify affected product whereby the would apply a label to the product which reads "DO NOT USE GREEN LIGHT FUNCTIONALITY - NOT FDA CLEARED FOR USE". Customers are encouraged to complete and return the response form via email to: [email protected].

    Distribution

    US Nationwide

    Quantity

    1040 units