| TGA Action ID |
RC-2025-RN-00764-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CADD-Solis Ambulatory Infusion Pump
Product Code: CADD TSM |
| ARTG Number |
396633 |
| Unique Device Identifier (UDI) |
CADD TSM |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Technical Service Manual (TSM) has been updated for the CADD-Solis Ambulatory Infusion Pump to include further information on the Downstream Occlusion (DSO) Seal (with image examples), Installation / Quick Check-Out and Accuracy Testing. |
| Instructions for Customers/Users |
Biomedical engineers are to be aware of the updated Technical Service Manual, which is provided by the sponsor.
This action has been finalised on 9/12/2025. |
| Action Commencement Date |
5/09/2025 |
| Responsible Entity |
|
| Contact Information |
1800 654 949 - Smiths Medical Australasia |