BEUDAMED
    FDA Recall Terminated

    Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

    Recall: Z-2975-2018 · Initiated June 29, 2018

    Recall

    Recall Number
    Z-2975-2018
    Event Number
    80496
    Firm
    Quasar Bio-Tech, Inc.
    FEI Number
    3006182559
    Product Code
    OHS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 29, 2018
    Terminated
    August 27, 2019
    Address
    1465 Tallevast Rd, Sarasota, FL, 34243-5036

    Description

    Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

    Reason

    Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.

    Action

    Quasar Bio-Tech notified customers on about 06/20/2018 via URGENT PRODUCT RECALL letter. Instructions included place any current, affected inventory on hold and arrange for return to Quasar Bio-Tech, Inc. Customers were also instructed to complete and return the reply form. Questions or concerns should be directed to Quasar Bio-Tech, Inc., at 800-944-1523 or 941-306-5812.

    Distribution

    Nationwide distribution to CA, FL, GA, HI, IL, LA, MD, NE, NY, OH, TX, VA, WA, WI. Worldwide distribution to Australia, China, Netherlands, United Kingdom

    Quantity

    6,783 units total