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Capiox fx25 hollow fiber oxygenator with integrated arterial filter
Official notice
9 Mar 2023
Last checked
9 Mar 2023
An official Health Canada notice concerns Capiox fx25 hollow fiber oxygenator with integrated arterial filter. 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. Published 2023-03-09.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73122
Official notice
2023-03-09
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Terumo Cardiovascular, Capiox Fx25 Hollow Fiber Oxygenator With Integrated Arterial Filter.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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