Recall Z-0945-05 ยท LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Boston Scientific Corporation
Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Silicone Catheter, Catalog #45-336, Material #M001453360. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
| Date | Jun 30, 2005 (initiated Jun 8, 2005) |
| Status | Terminated |
| Reason | Potential for port housing separation after implantation. |
| Root cause | Other |
| Action | A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible. |
| Distribution | Product shipped to 56 medical facilities throughout the U.S. |
| FDA record | Open on fda.gov |