Recall Z-1754-2020 ยท IME Pack, Hot Or Cold, Reusable
KT Health, LLC
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
| Date | Sep 16, 2019 |
| Status | Terminated |
| Reason | If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user. |
| Root cause | Unknown/Undetermined by firm |
| Action | Recall notifications were sent out on 9/16/2019 by letter to distributors. Firm indicated they used first class mail, email or facsimile. The notice informs users that the Company has received reports of product failures resulting in the release of the hot liquid from the Heat Gel-Core Insert component (orange ball) after being heated in the microwave. These included five reports of skin contact resulting in temporary or medically reversible adverse health consequences (first-degree burns and possibly one second degree burn), one of which required medical treatment. There were also four repor |
| Quantity | 94,554 |
| Distribution | US Nationwide distribution, no Government Consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.