FDASeptember 27, 2016device
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water thr...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascular us salesmaquetmaquet cardiovascular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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