Recall Z-1112-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Boston Scientific Corporation
PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
| Date | Aug 10, 2005 (initiated May 25, 2004) |
| Status | Terminated |
| Reason | Kits labeled to contain 0.028" guidewire contain 0.038" guidewire. |
| Root cause | Other |
| Action | Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location. |
| Quantity | 290 |
| Distribution | 278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963806 | CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) Bmw Medical, Inc., Dec 12, 1996 |