FDA Recall
Terminated
Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Recall: Z-0160-2007
·
Initiated October 5, 2006
Recall
- Recall Number
- Z-0160-2007
- Event Number
- 36516
- Firm
- Cook Endoscopy
- FEI Number
- 1037905
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 5, 2006
- Posted
- November 8, 2006
- Terminated
- December 15, 2006
- Address
- 5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206
Description
Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Reason
Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
Action
Cook Ireland customers were notified by letter via email on 10/13/2006.
Distribution
Worldwide.
Quantity
20 units