Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
- Company
- 2K Innovations Inc.
- Recall Initiated
- April 15, 2016
- Terminated
- August 7, 2019
- Recall Number
- Z-1806-2017
- Quantity
- 22,757 items in total
- Firm Location
- Saint Augustine, FL
Reason for Recall
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Distribution
Nationwide Distribution
Lot / Code Info
Item #VH-KNEE
Root Cause
Labeling False and Misleading
Action Taken
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.