Events

Recall of ConMed Suction Coagulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConMed Electrosurgery.

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
    53545
  • Event Risk Class
    Class 2
  • Event Number
    Z-0165-2010
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85814
  • 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
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    One production lot of suction coagulators received eto sterilization instead of gamma radiation sterilization.
  • Action
    Recalling firm notified all distributors by phone from 9/30 - 10/1/09. All customers were notified by letter titled "URGENT: DEVICE RECALL" dated 09/30/2009 on 10/2/2009. Customers were instructed to check their inventory for the affected product, complete the reply form and return affected product. For questions, please contact Damaris Velez or Jeff Dickinson of ConMed Electrosurgery at 800-552-0138, ext 5225 or email succoagrecall AT conmed.com.

Device

ConMed Suction Coagulator
  • Model / Serial
    Lot #: 09GHL001
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA
  • Product Description
    * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** || * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE || ***** || LOT 09GHL001 July 2014 || MADE IN CHINA ** CONMED CORPORATION || 525 FRENCH RD, UTICA, NY USA 13502"
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • Manufacturer Address
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA