| TGA Action ID |
RC-2025-RN-00885-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FreeGo Screwcap Set with ENFit stopcock port and connector, FreeGo ENPlus Feed Bag set with ENFit stopcock port and connector
Product Codes: S790, Y675
UDI: 05391503602385, 05391503602330
Lot Numbers: All |
| ARTG Number |
107276 |
| Unique Device Identifier (UDI) |
05391503602385, 05391503602330 |
| Action Type |
Product Alert |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Through post market surveillance, Abbott discovered that some customers were using the FreeGo Enteral Feeding Sets in a manner inconsistent with the labelling which has the potential to pose serious health risks.
While using two pumps at the same time, the enteral feeding set for fluids was attached at the stopcock port of the other enteral feeding set, and the stopcock/flush port of this second set was manipulated to be operated in a three-way function. This configuration is not supported by Abbott’s IFU. Any configuration involving two pumps and a shared giving set constitutes abnormal use and are not accounted for in the device design.
When used in this configuration, the Enteral pump fails to alarm for occlusion out of pump.
There have not been any reported serious adverse events to date. |
| Instructions for Customers/Users |
When used according to the manufacturer’s Instructions for Use, FreeGo remains safe and trained users may continue to use it with confidence.
For All Users:
•Carefully adhere to the FreeGo feeding set and pump IFU.
•Do not force the handle of the flush port on the feeding set past the physical stop.
•Do not connect a second feeding set to flush port.
For the Health Care Professionals:
•Reinforce the information in the IFU with all users and caregivers-such as family members, nurses and homecare givers.
•Ensure this information is available at the point of pump use and that the IFU are available to the user.
This action has been closed out on 09/02/2026. |
| Action Commencement Date |
14/10/2025 |
| Responsible Entity |
|
| Contact Information |
1800 819 831 - Abbott Pump Centre |