FDAFDA · Food and drugs·Recall number Z-0218-2022
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 tree.
Published November 24, 2021 · Recall initiated: October 1, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for distal tip dislodgement or separation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cordis Corporation
- Distributor
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- Lot
- Product Code: SF06150MB; Lot No. 266415, 266417, and 266419
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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