| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00627-1 |
| Product Name/Description |
t:slim X2 Insulin Pump
Product code: 1006419
software version of 6.4.1 or prior
ARTG 304681
(Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/05/2022 |
| Responsible Entity |
|
| Reason/Issue |
There are potential risks when using the pump within its normal specifications resulting in a loss of therapy. Software updates are planned by the sponsor to mitigate these risks. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
AMSL advises users that the Tandem pump may continue to be used as described in the User Guide. Users are advised to have an alternate means of insulin therapy available. Users should update their pumps to the latest software version as soon as possible.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
AMSL - diabetes@amsl.com.au - 1300 851 056 |