Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Bost
FDA device recall Z-1895-2009 · posted 2009-09-02 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The clip may not deploy or, if deployed, the clip may not release from the tissue.
- Action taken
- Consignees were notified by an "Urgent Recall Letter " dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FHN
- Quantity affected
- 217
- Distribution
- Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.
- Date initiated
- 2009-06-17
- Date posted
- 2009-09-02
- Date terminated
- 2010-10-08
- Location
- Quincy, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESOLUTION HEMOSTASIS CLIPPING DEVICE (K040148) | Boston Scientific Corp | 2004-04-22 |