Recall Z-2104-2019
Terumo Cardiovascular Systems Corporation · initiated June 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Numbers: XA21, XA29, XC04, XC18, XD05, XD27
Reason for recall
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
FDA-determined 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
Details
- Recall number
- Z-2104-2019
- Initiated
- June 14, 2019
- Terminated
- June 11, 2020
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 123 units
- Distribution
- MI Foreign: Japan, Belgium
- Recalling firm
- Terumo Cardiovascular Systems Corporation, Elkton, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2101-2019 Class II | Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RECapiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 06/14/2019Terminated |
| Z-2102-2019 Class II | Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RWCapiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 06/14/2019Terminated |
| Z-2103-2019 Class II | Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan…Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component | 06/14/2019Terminated |