| TGA Action ID |
RC-2026-RN-00437-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Guedel Airway
Models:
Intersurgical One-piece Guedel Airway Size 00 ISO 5 Blue
Intersurgical One-piece Guedel Airway Size 00 Sterile
Intersurgical Guedel Airway Size 000 ISO 3.5 Sterile
Intersurgical Guedel Airway Size 000 ISO 3.5
Intersurgical Guedel Airway Size 00 ISO 5
Intersurgical Guedel Airway Size 000 ISO 3.5
Part Numbers: 1000035, 1000035S, 1100050, 1100050S, 8000035, 8100050
Multiple lot numbers |
| ARTG Number |
224158, 257365 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
During manufacture, some Guedel Airway devices have been identified with occluded or partially occluded tips.
The hazard arising from this manufacturing fault depends on the level of occlusion. Potential problems include, but are not limited to, respiratory distress, laryngospasm, stridor, stenosis, oedema, neurological impairment, hypoxia, hypoxemia and cyanosis and their consequences. |
| Instructions for Customers/Users |
Customers are to:
- Identify and immediately quarantine any potentially affected products.
- Complete the Customer Response Form to arrange return of stock and credit. |
| Action Commencement Date |
15/06/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 8048 3302 - Intersurgical Australia |