Recall Z-2101-2019 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
| Date | Jun 14, 2019 |
| Status | Terminated |
| Reason | Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component |
| 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: TCVSCustomerResponseElkton@terumomedical.com |
| Quantity | 16 units |
| Distribution | MI Foreign: Japan, Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orie Terumo Cardiovascular Systems Corporation, Jun 22, 2018 |