| TGA Action ID |
RC-2026-RN-00358-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Endovision/Vimex Fluid Pump & Single-Use Tubing Set
All serial numbers and lot numbers
ARTG's: 427815 & 427816 (cancelled) |
| ARTG Number |
427815, 427816 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is the potential counterfeit products have been distributed.
The lack of sterility assurance, unknown origin of materials, and unverified compatibility of the tubing with the pump, may lead to a risk of infection, perioperative patient infection, or device malfunction (including tubing damage or uncontrolled flow) during the procedure.
No adverse events have been reported as a result of this problem. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine affected stock of all lots on hand to prevent further use.
- Return affected stock on hand.
No alternative stock is available. These products have been cancelled from the ARTG register and will no longer be supplied.
Please utilise alternate fluid management systems.
This action has been closed out on 19/08/2026 |
| Action Commencement Date |
21/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 810 018 - Priank Sinha, Matrix Medical Innovations |