Recall Z-2101-2019— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2101-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-14

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 (East Orientation) P/N: 3CX*NX19RE. 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 record

K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)Terumo Cardiovascular Systems Corporation·cleared 2018-06-22

K-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 (East Orientation) P/N: 3CX*NX19RE

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.