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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00891-1
Product Name/Description	Dochem Face Mask and Dochem Face Mask Type IIR All Batches ARTG 337858
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	8/07/2022
Responsible Entity	PACIFIC HEALTH 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). Pacific Health Pty Ltd has supplied batches of Dochem Face Mask and Dochem Face Mask Type IIR which are non-compliant with Fluid Resistance requirements. Dochem Face Mask and Dochem Face Mask Type IIR 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 from the market. Dochem Face Mask & Dochem Face Mask Type IIR 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 where a level 2 or 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, Dochem Face Mask & Type IIR 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; &/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	0402 325 668 - Justin Wang