| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01285-1 |
| Product Name/Description |
Animas 2020 Insulin Infusion Pumps (ambulatory infusion pump)
ARTG Number: 96120 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
There are a small number of units where the U4 component on the printed circuit board is misaligned potentially causing the pump to dispense all of the insulin in the cartridge. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
All users of the Animas 2020 Insulin Pump are receiving communication from the sponsor with work around instructions and instructions on how to return the affected pumps for a replacement pump |
| Contact Information |
1300 851 056 - Animas / AMSL Patients Support Line |