Recall Z-2973-2018 ยท OHS Light Based Over The Counter Wrinkle Reduction
Quasar Bio-Tech, Inc.
Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
| Date | Jun 29, 2018 |
| Status | Terminated |
| Reason | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| Root cause | Under Investigation by 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. |
| Quantity | 6,783 units total |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130225 | QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE Silverbay, LLC, D/B/A Quasar Bio-Tech, Jul 11, 2013 |