Recall Z-0340-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Boston Scientific Corporation
Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, MA 02472
| 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 | 300 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
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) Gerard Medical Enterprises, Inc., May 24, 1996 |