FDAFDA · Food and drugs·Recall number Z-2734-2014
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.
Published October 8, 2014 · Recall initiated: August 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm is distributing the Rejuvenator device without an approved 510(k).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baro-Therapies, Inc
- Distributor
- US Nationwide Distribution in the states of FL, GA, MS, TN and CO.
- Lot
- All Lots, Series and Codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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