Events

Recall of Device Recall Fixed Tip Electrosurgical Electrode.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encision, 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
    29430
  • Event Risk Class
    Class 2
  • Event Number
    Z-1074-04
  • Event Initiated Date
    2004-06-11
  • Event Date Posted
    2004-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33733
  • 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
    Electrosurgical tip may break or come off during use.
  • Action
    Customers were notified beginning 6/15/2004 by phone or visit.

Device

Device Recall Fixed Tip Electrosurgical Electrode.
  • Model / Serial
    Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
  • Product Description
    AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Manufacturer Address
    Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
  • Source
    USFDA