Events

Recall of Medicina Balloon Gastrostomy Kits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medicina 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
    16866
  • Event Initiated Date
    2014-06-25
  • 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: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    The mhra has deemed these items to be procedure packs and require a special ce mark which the devices do not currently have.
  • Action
    Product to be returned to supplier

Device

Medicina Balloon Gastrostomy Kits
  • Model / Serial
    Model: Models: EK16, EK18, EK20, Affected: All lots
  • Manufacturer
    Medicina Ltd

Manufacturer

Medicina Ltd
  • Manufacturer Parent Company (2017)
    Luan Srl
  • Source
    NZMMDSA