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.
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.
Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2021