FDA Device recall Z-2104-2019
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only w…
- FDA Device
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only w… by Terumo Cardiovascular Systems, citing capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2104-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-14 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | MI |
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
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Identifiers
| code_info | Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2104-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.