Recall Z-1802-2017 ยท IRT Pad, Heating, Powered
2k Innovations Inc.
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
| Date | Apr 15, 2016 |
| Status | Terminated |
| Reason | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| Root cause | Labeling False and Misleading |
| 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. |
| Quantity | 22,757 items in total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.