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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.

FDA Recall Z-2734-2014 · Posted 2014-09-30

Recalling FirmBaro-Therapies, Inc
Recall StatusTerminated
Product CodeCBF
Date Initiated2014-08-08
Date Terminated2015-08-06
Product Quantity10

Reason for Recall

The firm is distributing the Rejuvenator device without an approved 510(k).

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide Distribution in the states of FL, GA, MS, TN and CO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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