Recall Z-1598-2009 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cook Endoscopy
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
| Date | Jul 21, 2009 (initiated Jun 12, 2009) |
| Status | Terminated |
| Reason | The wire control port of these devices may be missing due to omission of a manufacturing activity. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 20 units |
| Distribution | International Distribution - Italy, Netherlands, Germany and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052051 | OMNI SPHINCTEROTOME Wilson-Cook Medical, Inc., Aug 5, 2005 |