Events

Recall of Fusion OMNI

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
    36516
  • Event Risk Class
    Class 2
  • Event Number
    Z-0160-2007
  • Event Initiated Date
    2006-10-05
  • Event Date Posted
    2006-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48786
  • 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
    ERCP catheter - Product Code KOG
  • Reason
    Injection through the flush port of these ercp catheters may be compromised due to omission of a manufacturing activity.
  • Action
    Cook Ireland customers were notified by letter via email on 10/13/2006.

Device

Fusion OMNI
  • Model / Serial
    Lot number W2243511, Expiration date 7/12/2009
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
  • Manufacturer
    Cook Endoscopy

Manufacturer

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