Health product recall

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 2M03 AM03 3CX*FX25RWC 3CX*FX25REC

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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