FDA-Device2019-08-07Class II
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Terumo Cardiovascular Systems Corporation
Hazard
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Sold states
MI Foreign: Japan, Belgium
Affected count
16 units
Manufactured in
125 Blue Ball Rd, N/A, Elkton, MD, United States
Products
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2101-2019Don't want to check this manually?
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