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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00276-1
Product Name/Description	Mask, surgical, single-use ARTG 348910 - Cancelled by Secretary as of 07 January 2022.
Recall Action Level	Sponsor
Recall Action Classification	Class II
Recall Action Commencement Date	10/02/2022
Responsible Entity	ADVANCED RM MEDICAL 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 cancelled the Device with ARTG number 348910 from the Register on the grounds that Advanced RM Medical Pty Ltd failed to comply with one or more conditions to which the inclusion of the Devices in the ARTG is subject (paragraph 41GN(1)(b) of the Act). Following cancellation of this ARTG entry, the sponsor failed to provide information to support claims made on safety, performance, presentation or quality of the affected Device as well as supply details.
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. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
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