| TGA Action ID |
RC-2026-RN-00921-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Aerogen Continuous Nebuliser Tube Set (CNTS) 60ml Syringe Pouched – Pack of 5
Product Code: AEG-AG-AS3085
Outer-pack lot numbers: 25I23009, 26E29001, 26F10013, 26G08043, 26I01012
Individual-pouch lot numbers: HM25044, HM26031, HM26031, HM26031, HM26031 |
| ARTG Number |
475829 |
| Unique Device Identifier (UDI) |
5391517930405 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The manufacturer has identified that some packs within the listed lots (see customer letter) of Aerogen CNTS 60 mL Syringe Pouched (Pack of 5), contain syringes incorporating an incorrect ENFit Enteral syringe barrel, marked “ENFit Enteral Syringe”.
The ENFit connector is incompatible with the Aerogen CNTS Syringe Cap and CNTS Tube Assembly, preventing use as intended. |
| Instructions for Customers/Users |
Prior to use, inspect each syringe for the barrel marking “ENFit Enteral Syringe”. Do not use any incorrect syringe identified. Segregate it and retain the associated packaging. Do not attempt to force a connection to the Aerogen CNTS components.
Correct Aerogen CNTS syringes can be returned to use. If there are no ENFit enteral syringes, the full Aerogen CNTS pack can be used as normal. |
| Action Commencement Date |
11/11/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies |