| 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 |
|
| 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 |