Events

Recall of Device Recall CottonLeung Biliary Stent

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
    48970
  • Event Risk Class
    Class 2
  • Event Number
    Z-2331-2008
  • Event Initiated Date
    2008-07-02
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72430
  • 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
    Biliary Catheter - Product Code FGE
  • Reason
    The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
  • Action
    Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.

Device

Device Recall CottonLeung Biliary Stent
  • Model / Serial
    Lot number W512494
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
  • Product Description
    Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. || Used to train obstructed biliary ducts.
  • Manufacturer
    Cook Endoscopy

Manufacturer

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