Events

Recall of ConMed Pyloric/Colonic Dilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conmed Endoscopic Technologies, 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
    37905
  • Event Risk Class
    Class 2
  • Event Number
    Z-0946-2007
  • Event Initiated Date
    2007-04-16
  • Event Date Posted
    2007-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52208
  • 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
    Pyloric/Colonic Dilator - Product Code KNQ
  • Reason
    Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
  • Action
    Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning product.

Device

ConMed Pyloric/Colonic Dilator
  • Model / Serial
    All lots manufactured from May 03, 2006 to December 14, 2006 which includes lot numbers/codes from 0605031 to 0612141. Lot code identification is as follows: For lot #0605031: 06 = year (2006); 05 = month (May); 03 = Day of Month (3rd); 1 = Manufacturing Shift Code (1st shift).
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-Devices distributed to medical facilities and distributors Nationwide (USA) and to distributors in the following countries: Australia, Belgium, Canada, Croatia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Spain and Sweden.
  • Product Description
    ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
  • Manufacturer
    Conmed Endoscopic Technologies, Inc.

Manufacturer

Conmed Endoscopic Technologies, Inc.
  • Manufacturer Address
    Conmed Endoscopic Technologies, Inc., 129 Concord Rd Bldg 3, Billerica MA 01821-4600
  • Source
    USFDA