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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00690-3
Product Name/Description Animas Insulin Infusion Pump (ambulatory insulin infusion pump), models - IR 2020, 1200

ARTG Number: 96120
Recall Action Level Consumer
Recall Action Classification Class I
Recall Action Commencement Date 20/07/2012
Responsible Entity Australasian Medical & Scientific Ltd
Reason/Issue Some patients experienced gradual wear of their insulin pump keypad that led to damage such as tearing or peeling of the edge of the keypad from the
insulin infusion pump. The buttons may not respond as intended. The potential hazard is that it may cause the pump to malfunction and may cause
under infusion or over infusion of insulin, resulting in hyperglycaemia or hypoglycaemia respectively.
Recall Action Recall
Recall Action Instructions Customers are requested to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of inspecting the pump. The Sponsor will replace any pumps that have a confirmed issue with the keypad.
Contact Information 1300 851 056 - Customer Technical Support