Recall Z-1901-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. The catheter is designed for external and internal percutaneous d
| Date | Aug 27, 2009 (initiated Jul 1, 2009) |
| Status | Terminated |
| Reason | Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the |
| Root cause | Labeling mix-ups |
| Action | Boston Scientific issued an "Urgent Medical Device Recall -Immediate Action Required" letter dated July 1, 2009. The letter was addressed to Risk Manger / Field Action Contact describing the problem and units affected and that further distribution or use of affected product should cease immediately. The Reply Verification Tracking Form enclosed with the letter was requested to be completed and returned. For further information, contact Boston Scientific at 1-508-683-6036. |
| Quantity | 79 units (1 box = 1 unit) |
| Distribution | Worldwide Distribution -- United States (AZ, AR, CO, DE, FL, GA, MI, MT, NE, NC, OH and WI), Spain, Finland and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023870 | FLEXIMA BILIARY CATHETER Boston Scientific/Medi-Tech, Dec 20, 2002 |