Recall Z-0160-2007 ยท KOG
Cook Endoscopy
Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
| Date | Nov 8, 2006 (initiated Oct 5, 2006) |
| Status | Terminated |
| Reason | Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity. |
| Root cause | Process control |
| Action | Cook Ireland customers were notified by letter via email on 10/13/2006. |
| Quantity | 20 units |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932205 | ERCP CATHETER, HYDROPHILIC COATED Wilson-Cook Medical, Inc., Jan 3, 1994 |