Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience ki…

Recall date

June 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2103-2019

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

MI Foreign: Japan, Belgium

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market