Events

Recall of PenEvac

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by I C Medical 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
    21266
  • Event Initiated Date
    2017-04-04
  • 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: Diploma Healthcare Group Ltd trading as Big Green Surgical New Zealand Ltd, Bendall and Cant, Level 7, Southern Cross Building, Cnr High & Victoria Streets, Auckland 1140
  • Reason
    Reports have been received that the penevac diathermy pen has had instances of self-activation, which can potentially lead to patient and staff injury., phase 2. the manufacturer is issuing this safety alert to remind users of the importance of following the instructions for use to ensure safe use of the penevac1 electrocautery pencils.
  • Action
    Product to be returned to supplier

Device

PenEvac
  • Model / Serial
    Model: , Affected: Lot#6406, Lot#6384 and 6391
  • Manufacturer
    I C Medical Inc

Manufacturer

I C Medical Inc