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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00072-1
Product Name/Description	Moosh P2 Respirator Mask Batch Number: 202004008 Expiry Date: 09/2022 ARTG 341112 - Cancelled by Secretary as of 09/11/2021
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/03/2022
Responsible Entity	MIRATRA 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 Devices with ARTG number 341112 from the Register upon the sponsors request, in accordance with section 41GL(d) of the Therapeutic Goods Act 1989 (the Act). Following TGA lab testing, samples of the device failed the test(s) for fluid resistance at level 3 (160mmHg) at the seam.
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, where fluid resistance is not required. 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 16/09/2024
Contact Information	0402776312 - MIRATRA PTY LTD