Medical device recalls Moderate risk

CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

Recall date
October 19, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0439-2024
FDA classification
Class II
Brand / firm
CardioQuip, LLC
Sold / distributed
US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA

Why it was recalled

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

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

What was recalled

CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

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