Boston Scientific Corporation
Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906
| Date | Jul 19, 2003 (initiated Jun 23, 2003) |
| Status | Terminated |
| Reason | Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa |
| Root cause | Other |
| Action | Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return. |
| Quantity | 30 units |
| Distribution | Japan, Italy, France, Turkey, Israel, Finland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955293 | FIBERED PLATINUM COIL, .035 TYPE Target Therapeutics, Feb 6, 1996 |