Recall Z-1577-05 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Angiomed Gmbh
Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm Catalog Number: LXB08060
| Date | Sep 24, 2005 (initiated Jul 28, 2005) |
| Status | Terminated |
| Reason | Biliary Stents may malfunction and cause failure to expand, fracture, incomplete deployment, inaccurate positioning, migration, or lumen perforation. |
| Root cause | Other |
| Action | On 7/26/05, Angiomed notified by telephone and follow-up letter Conmed Endoscopic Technologies, Billerica, MA [ the US distributor of the Bard Luminexx Endoscopic Biliary Stent ]. ConMed has issued recall notification letters dated 7/28/05 to the US customers of this recall. |
| Quantity | 204 |
| Distribution | Natiowide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031186 | LUMINEXX ENDOSCOPIC BILIARY STENT C.R. Bard, Inc., May 6, 2003 |