Recall Z-0324-2018 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cordis Corporation
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
| Date | Nov 15, 2017 |
| Status | Terminated |
| Reason | Potential for cracked luer hubs |
| Root cause | Nonconforming Material/Component |
| Action | On November 15, 2017 the firm sent letter to their customers indicating the following: The purpose of this communication is to inform you of a potential leakage scenario with the S.M.A.R.T. Flex Biliary Stent System. The leak may occur due to potentially cracked hubs in some units from within the 29 lots listed in this letter. Inspection details: As stated in the Instructions for use, users are warned that the device should not be used if the outer sheath cannot be flushed. Inspect for leakage during preparation of the device. Leakage may be more likely in the affected product due to cracks i |
| Quantity | 511 |
| Distribution | Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the 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 |