Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
- Recall date
- June 14, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2101-2019
- 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 With Reservoir (East Orientation) P/N: 3CX*NX19RE
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