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Health Canada Medical devices

Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter

Issued March 9, 2023
Issue
Terumo Cardiovascular Systems (Terumo CvS) has discovered that 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. Recall start date: February 24, 2023.
Hazard description
Performance
Product
Product name
Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
Reference
ID
RA-73122