Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-
Recalled Product
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.
Hazard / Issue
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.
Issued by
FDA
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