Recall Z-1346-2023 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
| Date | Apr 5, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 3/1/23 was sent to customers. RECOMMENDED ACTIONS 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. Terumo CVS will credit the user s accounts for returned, unused products. AFFECTED POPULATION The affected population is all patients on which an impacted Capiox NX, RX or FX Oxygenator is used. CUSTOMER INSTRUCTIONS - Review this Medical Device Recall notice and ensure that all users receive notice of this issue. Refer t |
| Quantity | 84 units |
| Distribution | US Nationwide. Belgium, Canada, Costa Rica, Thailand. |
| 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 |