Z-2734-2014 Class II Terminated
FDA device recall Z-2734-2014 was initiated by Baro-Therapies, Inc on August 8, 2014 and is designated Class II. Reason for recall: The firm is distributing the Rejuvenator device without an approved 510(k). The recall status is terminated (terminated August 6, 2015). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2014
- Initiation Date
- August 8, 2014
- Termination Date
- August 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product 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 for Recall
The firm is distributing the Rejuvenator device without an approved 510(k).
Distribution Pattern
US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
Code Information
All Lots, Series and Codes