Events

Recall of Device Recall Quantum TTC Biliary Balloon Dilation Catheter

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
    37213
  • Event Risk Class
    Class 2
  • Event Number
    Z-0520-2007
  • Event Initiated Date
    2007-01-24
  • Event Date Posted
    2007-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50117
  • 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
    Balloon Dilator - Product Code KNQ
  • Reason
    The graphic label is incorrect, it lists 6mm/ 18fr. the product label is correct, it lists 10mm/ 30fr.
  • Action
    Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.

Device

Device Recall Quantum TTC Biliary Balloon Dilation Catheter
  • Model / Serial
    Order number QBD-10X3, Lot number W2287708
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including NY and TX in USA, Australia, Canada and India.
  • Product Description
    Quantum TTC Biliary Balloon Dilation 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