Terumo Cardiovascular Systems Corporation Recall 91775
Description: CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Terumo Cardiovascular Systems Corporation Recall 91775 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1346-2023 |
| Event ID | 91775 |
| Event Description | CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE |
| Product Type | Devices |
| Distribution | US Nationwide. Belgium, Canada, Costa Rica, Thailand. |
| Quantity | 84 units |
| Recall 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. |
| Device Classification | 20230412 |
| Device Code Info | UDI-DI: (01)00699753450868; Lot Number AM03 |
| Center Classification Date | 20230405 |
| Recall Initiation Date | 20230301 |
| Recalling Firm | Terumo Cardiovascular Systems Corporation |
| Initial Notification | Letter |
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