Recall Z-1754-2020— KT Health, LLC
Class II · Terminated
Class II FDA medical device recall by KT Health, LLC, initiated 2019-09-16, terminated 2021-10-01. FDA's recall record names no specific 510(k) clearance for this event. Product: KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired. Reason: If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user..
- Recalling firm
- KT Health, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-16
- Terminated
- 2021-10-01
- Firm location
- American Fork, UT, United States
Product description
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
Reason for recall
If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.