| TGA Action ID |
RC-2026-RN-00890-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Smoothbore Breathing Systems
Multiple product descriptions and lot numbers |
| ARTG Number |
226032, 226033 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
During the manufacture of these products, Tetrahydrofuran (THF) solvent is used to bond the soft connectors onto the Smoothbore tube. Following reports received from the market of disconnection of the soft connectors from the tube, our investigation and testing of internal stock has identified insufficient amount of solvent used to ensure a secure connection.
Disconnection of a connector from the Smoothbore tube may compromise or interrupt ventilation, potentially resulting in patient oxygen desaturation. |
| Instructions for Customers/Users |
1. Identify and immediately quarantine all affected product codes and batch/lot numbers. Do not use affected stock.
2. Complete the attached Customer Response Form and indicate on the form whether affected stock has been destroyed or requires collection.
Intersurgical Australia will issue a credit for affected stock returned or destroyed with our authorisation. If replacement products are required, please place a new order. |
| Action Commencement Date |
4/11/2026 |
| Responsible Entity |
|
| Contact Information |
02 8048 3300 - Intersurgical Australia |