Recall Z-0325-2009 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cook Endoscopy
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
| Date | Jan 5, 2009 (initiated Oct 30, 2008) |
| Status | Terminated |
| Reason | The wire control port may have been omitted during manufacture. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 11 |
| Distribution | Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052051 | OMNI SPHINCTEROTOME Wilson-Cook Medical, Inc., Aug 5, 2005 |