FDA recall Z-2104-2019

Terumo Cardiovascular Systems Corporation · Class II · device

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

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-2104-2019