Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2022-RN-00317-1

Batch number: AL091

Expiry date: 1/3/2025

ARTG: 333382 - Cancelled as of 09/02/2022
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 17/02/2022
Responsible Entity Icon International Pty Ltd t/a Icon Medipharm
Reason/Issue The Therapeutic Goods Administration (TGA) has undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG).

Icon International Pty Ltd T.A. Icon Medipharm has supplied batch AL901 of 3 PLY DISPOSABLE SURGICAL FACE MASK which have been cancelled from the ARTG under the request of the Sponsor.

Icon International Pty Ltd T.A. Icon Medipharm has supplied batch AL9091 which when tested by TGA Laboratories, failed level 3 fluid resistance (160mmHg).
Recall Action Product Defect Alert
Recall Action Instructions The TGA does not require the face masks to be physically recalled (or otherwise removed) from the market.

These masks should not be used in clinical or patient/caregiving scenario including hospital wards, operating theatres, general practice, nursing homes or during in-home care / support services where fluid resistance is required.

At the user’s discretion or where the use of face masks is mandated under the provisions of a state or territory public health order, these masks should only be used in non-clinical environments such as domestic households, retail shops, food and beverage outlets, public transport, outdoor settings, etc.

Customers should consider:
• quarantining the product;
• using them in another setting; and/or
• if they do not have alternatives, ensuring that a face shield is used in high risk settings.

This action has been closed out on 06/04/2022
Contact Information 0410 599 822 - Jakob Gajadhar