| TGA Action ID |
RC-2026-RN-00067-1 |
| Type of Product |
Medicine |
| Product Name/Description |
Fluorouracil 4,600mg in 0.9% Sodium Chloride in Surefuser + (2.1ml/Hr) for Intravenous Infusion
Batch: BW26019723
Expiry: 15/03/2026
ARTG Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
When the Surefuser was removed from its outer protective bag, it was noticed that the Surefuser bladder had leaked within the plastic housing. The spill was contained within the body of the device.
Given the nature of the product, this action was undertaken prior to TGA notification (Immediate Market Action as defined within the PRAC). |
| Instructions for Customers/Users |
The spill was contained within the bag and deemed not safe for patient use and discarded by the treating clinician prior to use. |
| Action Commencement Date |
27/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |