F-Decalin, F-Octane recall in Canada: impaired sterility
In plain language
This recall involves F-Decalin and F-Octane medical devices sold in Canada. They are being recalled because the secondary packaging might be perforated, which could impair sterility. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer for lot or serial numbers.
- Follow the return/repair steps in the official notice.
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Affected products
F-Decalin
Model: G-80115, G-80117
Lot: More than 10 numbers, contact manufacturer.
F-Octane
Model: G-80315, G-80317
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Impaired sterility
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: G-80115, G-80117, G-80315, G-80317
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?
Impaired sterility
What should consumers do?
Stop using the product immediately. Contact the manufacturer for lot or serial numbers. Follow the return/repair steps in the official notice.
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. Impaired sterility
When was this product recalled?
This product was recalled on May 3, 2019.