Recall Z-0218-2022 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
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.
| Date | Oct 1, 2021 |
| Status | Open, Classified |
| Reason | There is a potential for distal tip dislodgement or separation. |
| Root cause | Process control |
| Action | The firm, Cordis, sent an "Urgent MEDICAL DEVICE RECALL" letter dated 10/1/2021 to its consignees/customers: In the US: The letter and Acknowledgement Form was sent to the following two (2) individuals in each account: Materials Director, and Risk Manager. The delivered letter will be followed up as necessary by phone, until signed Acknowledgement is received, or best effort attempt has occurred. For Affiliate countries: A copy of the letter sent to the affiliates by email. Reconciliation within the country will be performed by the affiliate. A summary statement that the notification is comple |
| Quantity | 26 units |
| Distribution | US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121125 | FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM Flexible Stenting Solutions, Inc., Jul 6, 2012 |