Cordis Corporation Recall 88821
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.
Cordis Corporation Recall 88821 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0220-2022 |
| Event ID | 88821 |
| Event 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 Type | Devices |
| Distribution | US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada. |
| Quantity | 4 units |
| Recall Reason | There is a potential for distal tip dislodgement or separation. |
| Device Classification | 20211124 |
| Device Code Info | Product Code: SF10100SB; Lot No. 266586 |
| Center Classification Date | 20211112 |
| Recall Initiation Date | 20211001 |
| Recalling Firm | Cordis Corporation |
| Initial Notification | Letter |
| Similar To |