FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Sale
FDA device recall Z-0325-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The wire control port may have been omitted during manufacture.
- Action taken
- Cook Ireland (distributor) was contacted via email on 10/30/08 and was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. A response sheet was attached. Recall status reports will be issued monthly. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Should you have any questions, please contact Cook Endoscopy Customer Quality Assurance Department at 1-336-744-0157.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 11
- Distribution
- Ireland
- Date initiated
- 2008-10-30
- Date posted
- 2009-01-05
- Date terminated
- 2009-04-07
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNI SPHINCTEROTOME (K052051) | Wilson-Cook Medical, Inc. | 2005-08-05 |