| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00587-1 |
| Product Name/Description |
Medtronic Paradigm Insulin Infusion Sets
Multiple model numbers
ARTG number: 119216 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic Diabetes has become aware of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the connector on the affected sets. If this occurs, the insulin can temporarily block the vents in the connector that allow the pump to properly prime. Exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is providing additional safety information to consumers and health professionals to ensure the vents in the connector are not blocked. The devices instructions for use will be updated with this information. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-paradigm-insulin-infusion-sets-130621.htm . |
| Contact Information |
1800 777 808 - Medtronic Diabetes Helpline |