Z-2103-2019Class II

Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into...

Name: Z-2103-2019 Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2019-06-14
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2019-06-14 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the... on 2019-06-14. FDA classified it as Class II and gives the reason as "Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2103-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-14
Posted: 2019-07-30
Terminated: 2020-06-11
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Terumo issued Urgent Medical Device Notification letter dated June 13 2019 via FedEx mailing executed on 6/14/2019 advising of the problem, health risk and action to take: Terumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET Terumo Recall Fax: 1.410.392.7183 Terumo Recall Email: [email protected]
Quantity in commerce: 78 units
Distribution: MI Foreign: Japan, Belgium
Product codes and lots: Lot Numbers: XA28, XC12, XC25, XD05, XD27

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2103-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2101-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2102-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2103-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2104-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code DTZ

K180950Class IITerumo 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)