Z-1598-2009

Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC...

Name: Z-1598-2009 Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC...
Creator: Cook Endoscopy
Published: 2009-06-12
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2009-06-12 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 on 2009-06-12. The reason FDA records is "The wire control port of these devices may be missing 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-1598-2009
Status: Terminated
Initiated: 2009-06-12
Posted: 2009-07-21
Terminated: 2010-04-06
Recalling firm: Wilson-Cook Medical Inc.
Product: Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: The wire control port of these devices may be missing due to omission of a manufacturing activity.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at [email protected] or 1-336-744-0157.
Quantity in commerce: 20 units
Distribution: International Distribution - Italy, Netherlands, Germany and Spain.
Product codes and lots: Product Order Number: FS-OMNI; Lot Number: W2454655.

Product code KNS

K052051Class IIOmni SphincterotomeWilson-Cook Medical, Inc. / cleared 2005-08-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)