Recall Z-0341-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Boston Scientific Corporation
Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.
| Date | Jan 6, 2006 (initiated Oct 28, 2005) |
| Status | Terminated |
| Reason | Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths. |
| Root cause | Other |
| Action | Boston Scientific letter dated 10/28/2005 sent via Federal Express. Customers (hospitals) instructed to remove and return product. |
| Quantity | 434 units |
| Distribution | DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962300 | CLAMPLESS VALVED CATHETER Bmw Medical, Inc., Sep 5, 1996 |