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Type of Product Medical Device
TGA Recall Reference RC-2021-RN-02255-1
Product Name/Description Proshield N95 Small Surgical Respirator

Batch number: 04NOV20

Expiry date: 04/11/2025

ARTG 342557
(BSN Medical (Aust) Pty Ltd - Surgical/medical respirator, single-use)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/11/2021
Responsible Entity BSN Medical (Aust) 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).

BSN Medical Pty Ltd has supplied batch 04NOV20 of Proshield N95 small surgical respirator which, when tested by the TGA, samples of the device demonstrated inconsistent testing results for fluid resistance. Batch 04NOV20 of Proshield N95 surgical respirator may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals.

No other batch of Proshield N95 surgical respirators are impacted by this issue.
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 a level 2 or 3 fluid resistance barrier 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 closed out on 28/02/2022
Contact Information 1300 276 633 - Customer Service