Recall of Neria Infusion Sets

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Unomedical 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
    18836
  • Event Initiated Date
    2015-07-16
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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: Pharmacy Retailing (NZ) Ltd t/a Clinect NZ Pty Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Reason
    There has been a slight increase in the number of reports of cases where the needles of these infusion sets have broken during use, including one australian adverse event report that may be related to this issue.
  • Action
    Product to be returned to supplier

Device

  • Model / Serial
    Model: 78-080-2738, 78-080-2731, Affected: Lots: 5006113; 5028915 & 5063419 (Expiry date on or before May-2019)
  • Manufacturer

Manufacturer