Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906
FDA device recall Z-1034-03 · posted 2003-07-19 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 30 units
- Distribution
- Japan, Italy, France, Turkey, Israel, Finland
- Date initiated
- 2003-06-23
- Date posted
- 2003-07-19
- Date terminated
- 2018-10-03
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FIBERED PLATINUM COIL, .035 TYPE (K955293) | Target Therapeutics | 1996-02-06 |