Reported Nov 24, 2021 · Ongoing
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant…
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 NW 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Lot codes and dates
- Product Code
SF09060SBLot No. 253349
- Product Code
- Amount recalled
- 9 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There is a potential for distal tip dislodgement or separation.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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