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Type of Product	Medical Device
TGA Recall Reference	RC-2021-RN-02342-1
Product Name/Description	MedSense Medical Disposable Mask Mask, surgical, single use Batch number: 20200801 Expiry date: 31/07/2022 ARTG 340295 - Cancelled by Secretary at Sponsors request on 30/07/2021
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	1/12/2021
Responsible Entity	Andatech 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). TGA testing indicated that the above medical device does not comply with the applicable provisions of the essential principles. In particular: • The design and production of the device may compromise health and safety [EP1]; • The design and construction may not conform with safety principles having regard to the generally acknowledged state of the art [EP2]; • The device may not be suitable for the intended purpose [EP3]; and • Samples of the device failed the test(s) for Fluid Resistance (Resistance against penetration by synthetic blood 80 mmHg). Inappropriate use of MedSense Medical Disposable Masks may inadequately prevent the spread of infectious agents between individuals. These masks have been cancelled from the ARTG at the request of the sponsor, under section 41GL(d) of the Therapeutic Goods 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 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 19/01/2022
Contact Information	03 8899 6900 - Andatech