S.M.A.R.T. FLEX BILIARY STENT SYSTEM recall in Canada: Tip dislodgement
In plain language
This recall involves the S.M.A.R.T. FLEX BILIARY STENT SYSTEM sold in Canada. It's being recalled because inadequate adhesive could cause the tip to dislodge or separate. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot number: 253349.
- Return the product as instructed by your healthcare provider.
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Affected products
S.M.A.R.T. FLEX BILIARY STENT SYSTEM
Model: SF09060SB
Lot: 253349
Why this matters
Tip dislodgement/separation
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: 253349
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: SF09060SB
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?
Tip dislodgement/separation
What should consumers do?
Stop using the product immediately. Check the lot number: 253349. Return the product as instructed by your healthcare provider.
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. Tip dislodgement/separation
When was this product recalled?
This product was recalled on October 15, 2021.