Trillium Affinity and Affinity NT recall in Canada: sterile barrier breach
In plain language
This recall involves Trillium Affinity and Affinity NT Cardiotomy/Venous Reservoirs (CVR) sold in Canada. They are being recalled because the sterile packaging may be breached. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the model numbers provided.
- Contact Medtronic Inc. for return instructions.
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Affected products
AFFINITY NT CARDIOTOMY/VENOUS RESERVOIR (CVR)
Model: 540 61399409462
Lot: All Unexpired Lots
TRILLIUM AFFINITY NT CARDIOTOMY/VENOUS RESERVOIR
Model: 540T
Lot: All Unexpired Lots
Why this matters
Sterile barrier breach
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 Unexpired Lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 540 61399409462, 540T
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?
Sterile barrier breach
What should consumers do?
Stop using the product immediately. Check the model numbers provided. Contact Medtronic Inc. for return instructions.
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. Sterile barrier breach
When was this product recalled?
This product was recalled on February 9, 2018.
Is the Trillium Affinity brand affected by this recall?
Yes, Trillium Affinity products are affected by this recall. This recall involves Trillium Affinity and Affinity NT Cardiotomy/Venous Reservoirs (CVR) sold in Canada. They are being recalled because the sterile packaging may be breached. Stop using the product and follow the return steps in the official notice.