Print version of this report

TGA Action ID	RC-2026-RN-00397-1
Type of Product	Medical Device
Product Name/Description	Clinell Universal Wipes Product Code: CW200AUS Lot/Batch Numbers: UJK4104323A, UJK1104623A, UJK6105123A, UJK3101424A, UJK2101524A, UJK6102224A, UJK5104323A, UJK2104623A, UJK1105223A, UJK5101424A, UJK3101524A, UJK1102324A, UJK6104323A, UJK3104623A, UJK2105223A, UJK6101424A, UJK4102224A, UJK1104423A, UJK5105123A, UJK3105223A, UJK1101524A, UJK5102224A
ARTG Number	299351
Action Type	Product Correction
Action Level	Retail
Hazard Classification	Class III
Reason for the Action	A labelling problem has been identified with a portion of Clinell Universal Wipes distributed in Australia between January 2024 and March 2026, where efficacy claims for Hepatitis B and Hepatitis C were included on a side panel of the packaging. While these claims are supported by testing to recognised European (EN) standards, testing to specific TGA requirements for these claims has not been performed.
Instructions for Customers/Users	Customers are to: - Continue to use the product in accordance with existing cleaning and disinfection protocols and the efficacy table on the product labelling. - Refer to the correct efficacy claims and follow the instructions regarding the informational poster in the customer letter. This action has been closed out on 24/08/2026
Action Commencement Date	22/05/2026
Responsible Entity	GAMA Healthcare Australia Pty Ltd
Contact Information	03 9769 6600 - GAMA Healthcare Australia