Device product
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Z-1346-2023
Product summary
- Event
- Event 91775
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-1346-2023
Official wording
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.
Code information: UDI-DI: (01)00699753450868; Lot Number AM03
Distribution pattern: US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Derived failure modes
-
Unknown
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.