Medical device recalls Moderate risk

Cincinnati Sub-Zero Products Inc recalls The Hemotherm 400CE 115v, containing power board p/n 39945

Recall date
November 7, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0654-2017
FDA classification
Class II
Brand / firm
Cincinnati Sub-Zero Products Inc
Sold / distributed
US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.

Why it was recalled

The device may not maintain water flow or temperature control.

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

What was recalled

The Hemotherm 400CE 115v, containing power board p/n 39945

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