Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Lot Number: WP17
Products Sold
Lot Number: WP17
Terumo Cardiovascular Systems Corporation is recalling Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE due to Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI
Page updated: Jan 10, 2026