Recall Z-1013-2019 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
| Date | Dec 26, 2018 |
| Status | Terminated |
| Reason | The sterile barrier may contain packaging seal defects. |
| Root cause | Other |
| Action | Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers. |
| Quantity | 18 units |
| Distribution | The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965147 | BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS Boston Scientific Corp, Jun 30, 1997 |