Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
This recall has been terminated (originally issued June 14, 2019).
- Recall Initiated
- June 14, 2019
- Terminated
- June 11, 2020
- Recall Number
- Z-2104-2019
- Quantity
- 123 units
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Distribution
MI Foreign: Japan, Belgium
Lot / Code Info
Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27
Root Cause
Process control
Action Taken
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