Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
This recall has been terminated (originally issued November 8, 2006).
- Company
- Cook Endoscopy
- Recall Initiated
- October 5, 2006
- Posted
- November 8, 2006
- Terminated
- December 15, 2006
- Recall Number
- Z-0160-2007
- Quantity
- 20 units
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
Distribution
Worldwide.
Lot / Code Info
Lot number W2243511, Expiration date 7/12/2009
Root Cause
Process control
Action Taken
Cook Ireland customers were notified by letter via email on 10/13/2006.
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