Events

Recall of NovoPen Echo

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Novo Nordisk A/S.

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
    21652
  • Event Initiated Date
    2017-07-04
  • 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: Novo Nordisk Pharmaceuticals Ltd, 58 Richard Pearse Drive, Airport Oaks, Auckland
  • Reason
    The manufacturer has detected that the insulin cartridge holder used in a small number of novopen echo batches may crack or break if exposed to certain chemicals, for example certain cleaning agents. however when cleaning the pen as described in the novopen echo user guide, there is no reason to believe that cracking of the cartridge holder will occur.
  • Action
    Product to be returned to supplier

Device

NovoPen Echo
  • Model / Serial
    Model: , Affected: Batch Numbers, EVG3310-6, EVG4252-2, FVG8412-3, FVG8415-1
  • Manufacturer
    Novo Nordisk A/S

Manufacturer

Novo Nordisk A/S