| TGA Action ID |
RC-2026-RN-00126-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
IV Line Volumed Set, Polypropylene, 330cm, 2x Needle Free Connectors, Anti Reflux Valve
Part Number: 1313300941
Lot Number: 25PH367 |
| ARTG Number |
326043 |
| Unique Device Identifier (UDI) |
08052747958054, 18052747958051 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The anti-reflux valve of lot 25PH367 was fitted upside down.
When the user is priming the line, the defect prevents the line from being filled with fluid. Therefore, the infusion cannot commence.
This action was undertaken prior to notification to the TGA. |
| Instructions for Customers/Users |
Customers were advised to stop using part no 1313300941, lot 25PH367 and remove it from clinical circulation.
This action has been closed out on 24/02/2026. |
| Action Commencement Date |
20/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 037 867 - Arcomed |