Home / Recalls / Medical Devices
Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for bl
Recalled August 4, 2021 · FDA recall Z-2140-2021 · Maquet Medical Systems USA
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. · FDA Class II
Units
33
Sold at
Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
Description
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.
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.
Manufacturer(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →