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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00370-1
Product Name/Description	Biofil Level 3 Surgical Mask Batch 202009F01 ARTG 336077 (Platinum Closing Pty Ltd - Mask, surgical, single use)
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	19/04/2023
Responsible Entity	Platinum Closing 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) Platinum Closing Pty Ltd has supplied a batch of surgical face mask, which when tested by the TGA failed fluid resistance testing.
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.”
Contact Information	0452 466 114 - Burak Kamit