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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00347-1
Product Name/Description	Ripe Doctors KN95 Airway protection face mask Batch number: 4007100315 ARTG 334208 - Cancelled as of 26/07/2021
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/02/2022
Responsible Entity	MCG ELECTRONICS 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). MCG Electronics Pty Ltd has supplied batches of RIPE DOCTORS KN95 Face Masks which have been cancelled from the ARTG as the 20 repeated usage and Virus protection advertised on the product could not be established as per the TGA requested standards. RIPE DOCTORS KN95 are not fit for medical use and should only be used in non-clinical settings.
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 closed out on 12/12/2023
Contact Information	0406 643 013 - Pedram Elikaei