Events

Recall of Quantum TTC Biliary Balloon Dilator

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

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
    27261
  • Event Risk Class
    Class 3
  • Event Number
    Z-1292-03
  • Event Initiated Date
    2003-09-15
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29578
  • 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
    Dilator, Esophageal - Product Code KNQ
  • Reason
    The product was labeled 'esophageal', but contained a 'biliary' ballon.
  • Action
    The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned.

Device

Quantum TTC Biliary Balloon Dilator
  • Model / Serial
    W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. CA, FL, IL, IN, IA, KS, LA, MI, MO, NJ, NC, OH, OK, TX, VA, WA, WI and foreign accounts in Canada, England, India, Japan, Korea, Mexico and Uruguary,
  • Product Description
    Quantum TTC Biliary Balloon Dilator
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc
  • Manufacturer Address
    Wilson-Cook Medical Inc, 4900 Bethania Station Rd, & 5951 Grassy Creek Blvd., Winston-Salem NC 27105
  • Source
    USFDA