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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00668-1
Product Name/Description	Gemini Dispoable Surgical Masks Batch number: 2020072801 Expiry date: 28/07/2022 ARTG 335052 - Cancelled as of 07/03/2022
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/04/2022
Responsible Entity	Mediquip 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). Mediquip Pty Ltd has supplied batch 2020072801 under ARTG 335052 which when tested by TGA Laboratories, failed level 2 fluid resistance (120mmHg). The TGA has cancelled the device from the ARTG under the request of the Sponsor in accordance with section 41GL(d) of the Therapeutic Goods Act 1989 (the Act).
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/dental practices, nursing homes or during in-home care / support services where level 2 fluid resistance is required. 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, Gemini Disposable Surgical Masks may also 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 where level 2 fluid resistance is not required; 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 20/08/2024
Contact Information	1300 246 349 - Mediquip Pty Ltd