Events

Recall of Device Recall Disposable AEM Cord

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
    29563
  • Event Risk Class
    Class 2
  • Event Number
    Z-1132-04
  • Event Initiated Date
    2004-07-09
  • Event Date Posted
    2004-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34118
  • 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
    Firm found pinholes in packaging which would compromise sterility.
  • Action
    Affected customers were notified by fax or mail on 7/15/2004.

Device

Device Recall Disposable AEM Cord
  • Model / Serial
    REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
  • Product Description
    Encision ES4107 Disposable AEM Cord, Sterile.
  • Manufacturer
    Encision, Inc.

Manufacturer

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