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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00476-1
Product Name/Description	Longteng Disposable Surgical Medical Mask Batch numbers: 200508 and 200418 Expiry date: 07/05/2022 and 18/04/2022 ARTG 333976 - Cancelled as of 10/03/2022
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	11/03/2022
Responsible Entity	C&D International Trading 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). C&D International Trading Pty Ltd has supplied batches of Disposable Surgical Medical Mask which, when tested by the TGA, demonstrated non-conformance with the Medical Device Essential Principles. Particularly: - Batch 200508 failed fluid resistance testing at level 2 (120mmHg). - Batch 200418 failed visual inspection (Nose piece was not adequately affixed) 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 12/04/2022
Contact Information	TBC