Cincinnati Sub-Zero Products LLC recalls Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circula…

Recall date

November 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0629-2018

FDA classification

Class II

Brand / firm

Cincinnati Sub-Zero Products LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.

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

What was recalled

Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.