Events

Recall of FSOMNI, Fusion OmniTome

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50118
  • Event Risk Class
    Class 2
  • Event Number
    Z-0325-2009
  • Event Initiated Date
    2008-10-30
  • Event Date Posted
    2009-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74761
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endoscopic electrosurgical unit - Product Code KNS
  • Reason
    The wire control port may have been omitted during manufacture.
  • 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.

Device

FSOMNI, Fusion OmniTome
  • Model / Serial
    Lot number W2501093
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Ireland
  • Product Description
    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.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Manufacturer Address
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA