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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00363-1
Product Name/Description	Animas 2020 and Animas IR 1200 Insulin Pumps ARTG Number: 96120
Recall Action Level	Consumer
Recall Action Classification	Class I
Recall Action Commencement Date	18/05/2015
Responsible Entity	Australasian Medical & Scientific Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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.
Contact Information	1300 851 056 - Animas AMSL Customer Support Line