Medical device recall in Canada: Coseal, Floseal, Hemopatch may be ineffective
In plain language
This recall involves Coseal Premix Surgical Sealant, Floseal Hemostatic Matrix, and Hemopatch Bicarb sold in Canada. They are being recalled because they may have been stored outside of recommended temperature ranges, which could affect their effectiveness. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check lot or serial numbers.
- Return the product as instructed.
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Affected products
Coseal Premix Surgical Sealant
Model: 934071
Lot: HA190767
Floseal Hemostatic Matrix
Model: 1505116
Lot: HA190743A
Hemopatch Bicarb
Model: 1506256
Lot: LK19B221
Why this matters
Product may be ineffective
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: HA190743A, HA190767, LK19B221
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1505116, 1506256, 934071
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?
Product may be ineffective
What should consumers do?
Stop using the product immediately. Check lot or serial numbers. Return the product as instructed.
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. Product may be ineffective
When was this product recalled?
This product was recalled on October 25, 2019.