Recall Z-1992-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
| Date | Aug 25, 2010 (initiated Apr 27, 2010) |
| Status | Terminated |
| Reason | Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile. |
| Root cause | Packaging |
| Action | Boston Scientific sent an "Urgent Medical Device Recall - Immediate Action Required" letter date April 27, 2010 to all consignees. The letter included instructions to immediately discontinue use and segregate the affected product for return, and complete and return by fax a Reply Verification Tracking Form. Customers with affected product were instructed to contact customer service at 866-868-4004 to obtain a Return Authorization (RGA) number, and package and ship the product to Boston Scientific. |
| Quantity | 85 |
| Distribution | Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, |
| 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 |