Z-1346-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units
Product Description
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Reason for Recall
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.
Distribution Pattern
US Nationwide. Belgium, Canada, Costa Rica, Thailand.
Code Information
UDI-DI: (01)00699753450868; Lot Number AM03