Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for b…

Recall date

July 14, 2021

Source

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

Recall number

Z-2140-2021

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.

Why it was recalled

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

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

What was recalled

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.