FDA Enforcement
Class II
Terminated
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
Recall: Z-1754-2020
·
Reported April 29, 2020
Enforcement
- Recall Number
- Z-1754-2020
- Event ID
- 85315
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- KT Health, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2020
- Initiation Date
- September 16, 2019
- Classification Date
- April 21, 2020
- Termination Date
- October 1, 2021
- Address
- 584 E 1100 S Ste 4, N/A, American Fork, UT, 84003-3887, United States
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
If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
Code Info
UPC Codes: 814179022226 814179022561 814179022721
Distribution
US Nationwide distribution, no Government Consignees.
Quantity
94,554