Quadrox-I Adult Oxygenator recall in Canada: Performance issue
In plain language
This recall involves the Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir sold in Canada. It's being recalled because it may not have a vital coating for biocompatibility. This issue is limited to one lot number. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot and model numbers.
- Contact the manufacturer for more information.
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Affected products
Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir
Model: VKMO 70000
Lot: 3000358089
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: 3000358089
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: VKMO 70000
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 lot and model numbers. Contact the manufacturer for more 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 August 30, 2024.
Is the MAQUET CARDIOPULMONARY GMBH brand affected by this recall?
Yes, MAQUET CARDIOPULMONARY GMBH products are affected by this recall. This recall involves the Quadrox-I Adult Oxygenator W/Integrated Hardshell Reservoir sold in Canada. It's being recalled because it may not have a vital coating for biocompatibility. This issue is limited to one lot number. Stop using the product and follow the return/repair steps in the official notice.