Events

Recall of Animas 2020 and Animas IR 1200 Insulin Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australasian Medical & Scientific 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
    RC-2015-RN-00363-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00363-1
  • 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
    Animas has identified a software limitation included in the animas 2020 and animas 1200 insulin pumps. the software included in the animas 2020 insulin pump only operates until midnight on dec. 31, 2015. after this date, the pump will no longer deliver insulin and will generate a call service alarm. this end of use date is not currently included in our product labelling. the calendar software included in the animas 1200 will not recognise and store any date in 2016 or beyond. after midnight on dec. 31, 2015, the pumps’ calendars will revert to a previous year. this calendar issue is not currently included in our product labelling. although these pump models will continue to deliver insulin, if patients are using a data management software program with their pump, they will notice inaccuracies in the reports because of the incorrect dates.
  • Action
    AMSL is replacing 2020 and IR 1200 pumps which are still in use with a new model Aminas Vibe Insulin Pump. This action has been closed-out on 24/08/2016.

Device

Animas 2020 and Animas IR 1200 Insulin Pumps

Manufacturer

Australasian Medical & Scientific Ltd