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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00676-1
Product Name/Description	Purist Australian - Mask, medical single use Batch number: 202003015 Production Date: 17/04/2020 ARTG 332818 (Cancelled at Sponsors request from 30 June 2021)
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	29/04/2022
Responsible Entity	Purist Australian
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). Purist Australia has supplied batch number 202003015 of Purist Australian - Mask, medical single use which have been cancelled from the ARTG in accordance with section 41GL(d) of the Therapeutic Goods Act 1989 (the Act) The TGA has not have received important information to determine whether these facemasks comply with the medical device essential principles or whether they are of satisfactory safety, performance, presentation or quality.
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; 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	0414 409 909 - Andre Mamfredas