Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
FDA device recall Z-1598-2009 · posted 2009-07-21 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The wire control port of these devices may be missing due to omission of a manufacturing activity.
- Action taken
- The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at cws.complaints@cookmedical.com or 1-336-744-0157.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 20 units
- Distribution
- International Distribution - Italy, Netherlands, Germany and Spain.
- Date initiated
- 2009-06-12
- Date posted
- 2009-07-21
- Date terminated
- 2010-04-06
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNI SPHINCTEROTOME (K052051) | Wilson-Cook Medical, Inc. | 2005-08-05 |