Recall of Ultra-Fine Insulin Syringe for use with U-100 insulin

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Becton Dickinson Pty 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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The blister package for some insulin syringes may exhibit an open seal potentially impacting on product sterility.No complaints or adverse events have been reported regarding this issue.
  • Action
    Users are requested to inspect stocks on hand and to quarantine affected units pending collection of the affected stock. A replacement or suitable credit will then be issued. This action has been closed-out on 31/08/2016.


  • Model / Serial
    Ultra-Fine Insulin Syringe for use with U-100 insulinCatalogue Number: 326725 Lot Number: 5019750 ARTG Number: 125064
  • Manufacturer