FDA Recall
Terminated
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
Recall: Z-2734-2014
·
Initiated August 8, 2014
Recall
- Recall Number
- Z-2734-2014
- Event Number
- 69053
- Firm
- Baro-Therapies, Inc
- FEI Number
- 3009829568
- Product Code
- CBF
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- August 8, 2014
- Posted
- September 30, 2014
- Terminated
- August 6, 2015
- Address
- 80 S Geronimo St, Unit 3, Miramar Beach, FL, 32550-8035
Description
The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
Reason
The firm is distributing the Rejuvenator device without an approved 510(k).
Action
Baro-Therapies issued a Correction Notice letter on August 11, 2014, to all affected customers. The letter stated they have suspended marketing of the device and plans to shut down their website until they receive clearance from the FDA. For questions or concerns contact the firm at (850) 654-0051.
Distribution
US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
Quantity
10