| Date Initiated by Firm |
April 15, 2016 |
| Create Date |
April 12, 2017 |
| Recall Status1 |
Terminated 3 on August 07, 2019 |
| Recall Number |
Z-1806-2017 |
| Recall Event ID |
76787 |
| Product Classification |
Pad, heating, powered - Product Code IRT
|
| Product |
Volt Resistance Heated Therapy Knee Wrap
Deep penetrating heat garment and wraps |
| Code Information |
Item #VH-KNEE |
Recalling Firm/
Manufacturer |
2k Innovations Inc.
110 Cumberland Park Dr Ste 205
Saint Augustine FL 32095-8901
|
| For Additional Information Contact |
Colby Wright
888-518-6871
|
Manufacturer Reason
for Recall |
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
|
FDA Determined
Cause 2 |
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 in Commerce |
22,757 items in total |
| Distribution |
Nationwide Distribution |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
