FDA Recall
Terminated
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
Recall: Z-1807-2017
·
Initiated April 15, 2016
Recall
- Recall Number
- Z-1807-2017
- Event Number
- 76787
- Firm
- 2k Innovations Inc.
- FEI Number
- 3010476958
- Product Code
- IRT
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- April 15, 2016
- Terminated
- August 7, 2019
- Address
- 110 Cumberland Park Dr, Ste 205, Saint Augustine, FL, 32095-8901
Description
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
Reason
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Action
2k Innovations sent e-mail communication from 04/15/2016 thru 09/09/2016 informing their consignees that the firm is no longer linking their products to any medical and therapeutic claims and that new labels and boxes will be corrected and the claims will be taken out of the website. For questions customers should call 888-518-6871, ext 700.
Distribution
Nationwide Distribution
Quantity
22,757 items in total