Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
Last updated
Summary
Product
Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter |
2M10 |
3CX*FX25RWC |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Terumo Cardiovascular Systems Corporation
125 Blue Ball Road, Elkton, Maryland, United States, 21921
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73122
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