FDA recall Z-1754-2020

KT Health, LLC · Class II · device

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 for recall

If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.

Distribution

US Nationwide distribution, no Government Consignees.

Key facts

Status
Terminated
Initiation date
2019-09-16
Report date
2020-04-29
Termination date
2021-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
American Fork, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1754-2020