Recall Z-2102-2019— Terumo Cardiovascular Systems Corporation
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2019-06-14, terminated 2020-06-11. It names one FDA 510(k) clearance: K180950. Product: Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW. Reason: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component.
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-14
- Terminated
- 2020-06-11
- Firm location
- Elkton, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.