Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-10
FDA device recall Z-0491-2009 · posted 2009-01-12 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- These devices may experience difficulty cocking and arming, resulting in an inability to use the devices.
- Action taken
- U.S. consignees were notified via letter dated 10/17/08, which informs them of the problem, instructs them to remove from use and quarantine the recalled lots and requests completion and submission of the Reply Verification Tracking form via fax at 508-683-5578. For questions about this recall, contact your local Boston Scientific representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 14,254 of all devices.
- Distribution
- Worldwide Distribution including USA and countries of Algeria, Austria, Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, M
- Date initiated
- 2008-10-17
- Date posted
- 2009-01-12
- Date terminated
- 2009-12-15
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EASY CORE BIOPSY SYSTEM (K040893) | Boston Scientific Corp | 2004-05-06 |