Events

Recall of Device Recall Monopolar Laparoscopic 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
    25368
  • Event Risk Class
    Class 2
  • Event Number
    Z-0470-03
  • Event Initiated Date
    2003-01-15
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25675
  • 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
    Reports of needle fixed-tip electrodes becoming loose or breaking off.
  • Action
    All consignees will be notified by phone or visit beginning 01/15/2003.

Device

Device Recall Monopolar Laparoscopic Electrode
  • Model / Serial
    Catalog # ES3521B. Lots FI, GC, GH, GL, HH, HI.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic distribution to LA, MA, MN, OR, UT and WA.
  • Product Description
    AEM Fixed-Tip Needle Electrode - 5mm, Reusable || REF/CAT ES3521B
  • Manufacturer
    Encision, Inc.

Manufacturer

Encision, Inc.
  • Manufacturer Address
    Encision, Inc., 4828 Sterling Drive, Boulder CO 80301
  • Source
    USFDA