| TGA Action ID |
RC-2025-RN-00565-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Guedel Airway
One-piece Guedel airway, size 2, ISO 8.0, green
One-piece Guedel airway, size 3, ISO 9.0, yellow
REF / Product Code: 1112080
Lots: 32415284, 32416250, 32420438
REF / Product Code: 1113090
Lots: 32421079, 32422296 |
| ARTG Number |
224158 |
| Unique Device Identifier (UDI) |
5030267050659, 5030267050680 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A non-conformance was raised for plastic burrs found inside the Guedel Airway during manufacture. The fault was caused by damaged production equipment contacting the inside of the Guedel Airway.
If the burr becomes detached and is inhaled, it could result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
The affected lot numbers have been distributed to hospitals and health services since the 4th of February 2025.
No reports of this problem have come from the market to-date. |
| Instructions for Customers/Users |
Customers are to immediately quarantine affected stock of listed lot numbers on hand to prevent further use and return it to Intersurgical Australia.
Replacement stock of unaffected lot numbers is available. Customers should contact customerservices@intersurgical.com.au to arrange replacement.
This action has been closed out on 08/04/2026 |
| Action Commencement Date |
20/06/2025 |
| Responsible Entity |
|
| Contact Information |
02 8048 3300 - Customer Service |