| TGA Action ID |
RC-2026-RN-00102-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ventilator Breathing Circuit for Non-invasive Ventilation Devices
Catalog Number: AMVC1792-156
Lot Numbers: 021025, 160924, 230725, 181024 |
| ARTG Number |
475290 |
| Action Type |
Recall / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer, Armstrong Medical, has received reports from customers describing holes and tears between the tubing and the purple cuff connector (of ventilator circuits and anaesthetic circuits). These defects have resulted in delays in treatment and required replacement of the breathing circuit. Following internal investigation, a manufacturing defect has been identified that may cause holes or tearing at the junction between the tubing and the purple cuff connector. This can occur during handling, including when replacing a filter.
No patient harm has been reported due to this problem. |
| Instructions for Customers/Users |
Customers are to:
1. Identify and quarantine all affected lots listed in Table 1 of the Customer Letter.
2. Cease use immediately.
3. Return all affected units following the instructions provided by your Breathing and Medical representative.
However, where a suitable alternative product cannot be sourced, continued use of the product is permitted in adherence with the following controls outlined in the Customer Letter.
This action was finalised on 28/10/2026. |
| Action Commencement Date |
18/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 335 333 - Breathing and Medical |