Recall Z-0730-2007 · FGE Stents, Drains And Dilators For The Biliary Ducts
Conmed Endoscopic Technologies, Inc.
Flexxus Endoscopic Biliary Stent, 7.5 Fr 10 mm diameter x 60 mm length Item Number: LXB10060
| Date | Apr 11, 2007 (initiated Mar 14, 2007) |
| Status | Terminated |
| Reason | Blue safety clip incorrectly placed on the stent may prevent deployment |
| Root cause | Other |
| Action | ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices. |
| Quantity | 1 UNIT |
| Distribution | Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan. |
| 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 |