Events

Recall of Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit

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-2013-RN-00374-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00374-1
  • 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
    There is a potential for the edge of the probe plus ii rotational knob to rub against the tyvek packaging, and in remote instances, puncture the tyvek creating a pin hole and potentially compromising the sterility of the device.
  • Action
    Johnson & Johnson Medical is recalling the potentially affected products.

Device

Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit
  • Model / Serial
    Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit Electrosurgery Probe Plus II Monopolar Electrosurgery Suction and Irrigation Shaft with: Hook Electrode - 5 mm (Code: EPS01)Spatula Electrode - 5 mm (Code: EPS02)Right Angle Electrode - 5 mm (Code: EPS03)ARTG Number: 125259Electrosurgery Probe Plus II Suction and Irrigation Shaft - 10 mm ( Code: EPS 11)ARTG Number: 124975 Laparoscopic Banding Kit ( Code: CK260)ARTG Number: 99301
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd