Events

Recall of TIC Insulin Syringe

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Tae-Chang Industrial Co 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
    22649
  • Event Initiated Date
    2018-02-22
  • 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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Reason
    The manufacturer has identified that the individual peel packaging of the 0.5ml syringe had been mislabelled with the information for the 1.0ml syringe in relation to the unit increments. the current device label "0.5ml single use syringe for 100 units or less in two unit increments" should read "0.5ml single use syringe for 50 units or less in one unit increments.".
  • Action
    Product to be returned to supplier

Device

TIC Insulin Syringe

Manufacturer

Tae-Chang Industrial Co Ltd