Sarasota, FL, United States
Quasar Bio-Tech, Inc. recalls
1 recall recorded since 2018, most recently on 29 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 June 2018
- Terminated
- 27 August 2019
- Reason
- Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2975-2018, Z-2974-2018, Z-2973-2018
- Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
- Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.