Z-0325-2009

FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road...

Name: Z-0325-2009 FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road...
Creator: Cook Endoscopy
Published: 2008-10-30
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2008-10-30 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook... on 2008-10-30. The reason FDA records is "The wire control port may have been omitted during manufacture". 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-0325-2009
Status: Terminated
Initiated: 2008-10-30
Posted: 2009-01-05
Terminated: 2009-04-07
Recalling firm: Wilson-Cook Medical Inc.
Product: FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: The wire control port may have been omitted during manufacture.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cook Ireland (distributor) was contacted via email on 10/30/08 and was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. A response sheet was attached. Recall status reports will be issued monthly. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Should you have any questions, please contact Cook Endoscopy Customer Quality Assurance Department at 1-336-744-0157.
Quantity in commerce: 11
Distribution: Ireland
Product codes and lots: Lot number W2501093

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)