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Type of Product Medical Device
TGA Recall Reference RC-2021-RN-02419-1
Product Name/Description Particulate Respirator FFP2 NR

Batch number: 200519

Expiry date: 31/05/2023

ARTG 337777
(Healthscope Operations PTY LTD - Surgical/medical respirator, single-use)
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 28/01/2022
Responsible Entity Healthscope Operations PTY LTD
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).

Healthscope Operations Pty Ltd has supplied batch 200519 of Particulate Respirator FFP2 NR which, when tested by the TGA, samples of the device demonstrated inconsistent testing results for fluid resistance at level 1. Batch 200519 of Particulate Respirator FFP2 NR may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals.
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 also may 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 reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 0409 078 751 - Jeremy McCristal