FDA-Device2021-08-04Class II
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.
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.
Sold states
Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
Affected count
33
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief