Capiox FX25 Oxygenator recall in Canada: performance issue
In plain language
This recall involves Capiox FX25 Hollow Fiber Oxygenators with Integrated Arterial Filters sold in Canada. They are being recalled because a component may be improperly bonded, which could lead to a leak. Healthcare professionals should contact the manufacturer for more information.
What to do
- Stop using the product immediately.
- Check the model and lot numbers.
- Contact the manufacturer for additional information.
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Affected products
Capiox FX25 Hollow Fiber Oxygenator With Integrated Arterial Filter
Model: 3CX*FX25REC, 3CX*FX25RWC
Lot: 2M10, 2M03, AM03
Why this matters
Performance issue
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 2M10, 2M03, AM03
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 3CX*FX25REC, 3CX*FX25RWC
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue
What should consumers do?
Stop using the product immediately. Check the model and lot numbers. Contact the manufacturer for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue
When was this product recalled?
This product was recalled on March 9, 2023.
Is the Terumo Cardiovascular Systems Corporation brand affected by this recall?
Yes, Terumo Cardiovascular Systems Corporation products are affected by this recall. This recall involves Capiox FX25 Hollow Fiber Oxygenators with Integrated Arterial Filters sold in Canada. They are being recalled because a component may be improperly bonded, which could lead to a leak. Healthcare professionals should contact the manufacturer for more information.