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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00362-1
Product Name/Description	Shengquan FFP2 Particle Filtering Half Mask Shengquan KN95 Particle Filtering Half Mask Unlabelled - Shengquan Respirator ARTG 340747
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	19/05/2023
Responsible Entity	Shengquan (Australia) High-Tech 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). Shengquan (Australia) High-Tech Pty Ltd has supplied batches of XYZ which when tested by TGA Laboratories, failed fluid resistance on the main body. Inappropriate use of Shengquan (Australia) High-Tech KN95 Respirators may inadequately prevent the spread of infectious agents (including COVID-19) between individuals, particularly patients and health care professionals in settings where a fluid resistance barrier is required
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 there is a risk of blood or body fluid splash or spray. 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 31/01/2024
Contact Information	No contact details available - Company has shut down