—#174208

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

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K180950
Affected lot / code info: Lot Numbers: XA28, XC12, XC25, XD05, XD27

Why it was recalled

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

Root cause (FDA determination)

Process control

Action the firm took

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: TCVSCustomerResponseElkton@terumomedical.com

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: MI Foreign: Japan, Belgium

Timeline

Recall initiated: 2019-06-14
Terminated: 2020-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174208. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.