| TGA Action ID |
RC-2026-RN-00038-1 |
| Type of Product |
Medicine |
| Product Name/Description |
FLUOROURACIL 4,750MG IN 0.9% SODIUM CHLORIDE IN SUREFUSER + (5ML/HR) FOR INTRAVENOUS INFUSION
Batch: BB25118341
Expiry: 12/01/2026
ARTG: Exempt |
| ARTG Number |
|
| Unique Device Identifier (UDI) |
n/a |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A Fluorouracil device was supplied in a 2-day 5mL/hr 250mL Surefuser instead of a 2-day 5mL/hr 250mL LV Infusor as ordered.
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 |
This product was nominated to be administered to the patient on 19/11/2025.
Customers should inspect their stock immediately to determine if you have any remaining stock and if so, quarantine affected stock on hand to prevent further use.
Please discard the affected batch as cytotoxic waste. |
| Action Commencement Date |
15/01/2026 |
| Responsible Entity |
|
| Contact Information |
03 9565 4400 - Slade Health Head Office |