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Terminated

Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

FDA Recall Z-2974-2018 · Posted None

Recalling FirmQuasar Bio-Tech, Inc.
Recall StatusTerminated
Product CodeOHS
Date Initiated2018-06-29
Date Terminated2019-08-27
Product Quantity6,783 units total

Reason for Recall

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

Firm 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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130225QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICESilverbay, LLC, D/B/A Quasar Bio-Tech · 2013-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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