Cook Endoscopy Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Brand
Cook Endoscopy
Lot Codes / Batch Numbers
Lot number W2243511, Expiration date 7/12/2009
Products Sold
Lot number W2243511, Expiration date 7/12/2009
Cook Endoscopy is recalling Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Sa due to Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
Recommended Action
Per FDA guidance
Cook Ireland customers were notified by letter via email on 10/13/2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026