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Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits

Recalled August 7, 2019 · FDA recall Z-2104-2019 · Terumo Cardiovascular Systems

Hazard
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component · FDA Class II
Units
123 units
Sold at
MI Foreign: Japan, Belgium

Description

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

Product
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Manufacturer(s)
Terumo Cardiovascular Systems Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits | RecallWatchUSA