Z-2974-2018 Class II Terminated
FDA device recall Z-2974-2018 was initiated by Quasar Bio-Tech, Inc. on June 29, 2018 and is designated Class II. 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. The recall status is terminated (terminated August 27, 2019). Affected quantity: 6,783 units total.
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2018
- Initiation Date
- June 29, 2018
- Termination Date
- August 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,783 units total
Product Description
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
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.
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
Code Information
Product Number DPA-024. UPC Code 0 91037 46143 8