Medical device recalls Moderate risk

Cincinnati Sub-Zero Products LLC, a Gentherm Company recalls Norm-O-Temp model 111Z

Recall date
June 20, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2355-2019
FDA classification
Class II
Brand / firm
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Sold / distributed
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Why it was recalled

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

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

What was recalled

Norm-O-Temp model 111Z

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