Recall Z-0344-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Boston Scientific Corporation
Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO. Firm on label: Boston Scientific, Natick, MA and Boston Scientific, Glens Falls, NY
| 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 | 97 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
| K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc., Oct 21, 1999 |