Medical device recall in Canada: Panocell-10 and Panocell-16
In plain language
This recall involves Panocell-10, Ficin Treated and Panocell-16 medical devices sold in Canada. They are being recalled because of incorrect antigen typing for a donor used in their manufacturing. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check lot numbers if provided.
- Return the product as instructed.
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Affected products
Panocell-10, Ficin Treated
Model: 0002385
Lot: 34457-E
Date codes: Exp: 2018-10-26
Panocell-16
Model: 0002332
Lot: 41531
Date codes: Exp: 2018-12-14
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 date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: Exp: 2018-10-26, Exp: 2018-12-14
- 3
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 34457-E, 41531
- 4
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 0002332, 0002385
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?
This recall involves Panocell-10, Ficin Treated and Panocell-16 medical devices sold in Canada. They are being recalled because of incorrect antigen typing for a donor used in their manufacturing. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check lot numbers if provided. 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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on January 11, 2019.