Events

Recall of ENSEAL G2 Curved and Straight Tissue Sealer Devices (used in endoscopic procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

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
    RC-2012-RN-01204-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01204-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Johnson & johnson medical advises that there is a potential for self activation while the device is in use, which could result in injury to patients or users (thermal damage).
  • Action
    Quarantine and return affected product to Johnson & Johnson Medical.

Device

ENSEAL G2 Curved and Straight Tissue Sealer Devices (used in endoscopic procedures)
  • Model / Serial
    ENSEAL G2 Curved and Straight Tissue Sealer Devices (used in endoscopic procedures)Multiple product codes All lots with expiration date from October 2013 to September 2017ARTG Number: 125257
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd