FDA recall Z-2102-2019
Terumo Cardiovascular Systems Corporation · Class II · device
Product
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
Reason for recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Distribution
MI Foreign: Japan, Belgium
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-14
- Report date
- 2019-08-07
- Termination date
- 2020-06-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Elkton, MD, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2019