SMART FLEX 10x100 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: SF10100SB; Lot No. 266586
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cordis Corporation
- Reason for Recall:
- There is a potential for distal tip dislodgement or separation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
SMART FLEX 10x100 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.
Product Codes/Lot Numbers:
Product Code: SF10100SB; Lot No. 266586
Distribution:
Distributed in: US, CA, FL, IN, LA, OH, OK, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0220-2022
Related Recalls
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.