Smart Flex 6x150 BIL recall
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary…
Why was Smart Flex 6x150 BIL recalled?
There is a potential for distal tip dislodgement or separation.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: SF06150MB; Lot No. 266415, 266417, and 266419
- Product
- SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary…
- Recalling firm
- Cordis Corporation
- Quantity
- 26 units
- Distribution
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)