Medical device recalls Moderate risk

KT Health, LLC recalls KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the thera…

Recall date
September 16, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1754-2020
FDA classification
Class II
Brand / firm
KT Health, LLC
Sold / distributed
US Nationwide distribution, no Government Consignees.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired

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