Recall Z-2734-2014
Baro-Therapies, Inc · initiated August 8, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: All Lots, Series and Codes
Reason for recall
The firm is distributing the Rejuvenator device without an approved 510(k).
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-2734-2014
- Initiated
- August 8, 2014
- Posted by FDA
- September 30, 2014
- Terminated
- August 6, 2015
- Product code
- CBF – Chamber, Hyperbaric
- Quantity
- 10
- Distribution
- US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
- Recalling firm
- Baro-Therapies, Inc, Miramar Beach, FL