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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 Medtronic Australasia Pty Ltd
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 .
Contact Information 1800 777 808 - Medtronic Diabetes Helpline