Events

Recall of Ethicon Electrosurgery Probe Plus II with Electrode

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ethicon Endo-Surgery 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
    14564
  • Event Initiated Date
    2013-04-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    There is a potential for edge of the probe plus ii rotational knob to rub against the tyvek(r) and in remote instances puncture the tyvek(r) creating a pin hole. due to the possibility that a tear in the tyvek(r) packaging may compromise the sterility of the device the stated setrility levels could not be assured for the product. the endopath probe pluss ii shaft is sold and labelled as "sterile".
  • Action
    Product to be returned to supplier

Device

Ethicon Electrosurgery Probe Plus II with Electrode

Manufacturer

Ethicon Endo-Surgery Inc