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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01530-1
Product Name/Description	OAPL FACE MASK DISPOSABLE 3PLY EARLOOP Batch number: 205029 Date of manufacture: 05/2020 ARTG 333823 - Cancelled as of 11/08/2022
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	14/12/2022
Responsible Entity	Orthotic & Prosthetic Centre 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). Orthotic & Prosthetic Centre (OPC) Pty Ltd has supplied batches of OAPL Face Mask Disposable 3 Ply Earloop which when tested by TGA Laboratories, failed fluid resistance testing at level 2 (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. OAPL Face Mask Disposable should not be used in that sort of clinical or patient/caregiving scenario including hospital wards, operating theatres, general practice, nursing homes or during in-home care / support services where a level 2/3 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, OAPL Face Mask Disposable 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; 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.
Contact Information	03 9681 9666 - Product Manager