Z-0160-2007

Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC...

Name: Z-0160-2007 Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC...
Creator: Cook Endoscopy
Published: 2006-10-05
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2006-10-05 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 on 2006-10-05. The reason FDA records is "Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0160-2007
Status: Terminated
Initiated: 2006-10-05
Posted: 2006-11-08
Terminated: 2006-12-15
Recalling firm: Wilson-Cook Medical Inc.
Product: Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Product code: KOG
Reason for recall: Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cook Ireland customers were notified by letter via email on 10/13/2006.
Quantity in commerce: 20 units
Distribution: Worldwide.
Product codes and lots: Lot number W2243511, Expiration date 7/12/2009

Product code KOG

K932205Class IErcp Catheter, Hydrophilic CoatedWilson-Cook Medical, Inc. / cleared 1994-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)