Edwards Lifesciences catheter recall in Canada: labelling issue
In plain language
This recall involves the Swan-Ganz Double Lumen Monitoring Catheter sold in Canada. It's being recalled because it is incorrectly labelled as MR safe. This could cause artifacts to appear during an MRI scan.
What to do
- Stop using the product immediately.
- Contact the manufacturer for more information.
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Affected products
Swan-Ganz Double Lumen Monitoring Catheter
Model: 110F5
Lot: All lots
Why this matters
Incorrect labelling
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 110F5
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?
Incorrect labelling
What should consumers do?
Stop using the product immediately. 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. Incorrect labelling
When was this product recalled?
This product was recalled on July 14, 2023.
Is the Edwards Lifesciences LLC brand affected by this recall?
Yes, Edwards Lifesciences LLC products are affected by this recall. This recall involves the Swan-Ganz Double Lumen Monitoring Catheter sold in Canada. It's being recalled because it is incorrectly labelled as MR safe. This could cause artifacts to appear during an MRI scan.