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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00480-1
Product Name/Description	OptiPro FFP2 Mask Batch number: 30082020 Expiry date: 20/08/2023 ARTG 339656 – Cancelled as of 06/10/2021
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	11/03/2022
Responsible Entity	Optimum Medical Australasia 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). The TGA has not have received important information to determine whether these facemasks comply with the required fluid resistance requirements in place for surgical/medical respirators. The TGA has cancelled the Devices supplied under ARTG number 339656 from the Register.
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.
Contact Information	TBC