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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00244-1
Product Name/Description	Estitch Australia Pty Ltd Mask, surgical, single use ARTG: 343245 - Mask, surgical, single use - Cancelled by Secretary 6/7/2023
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	23/03/2023
Responsible Entity	Estitch Australia 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). The TGA has cancelled the Devices with ARTG number 33245 from the Register as they failed to comply with the notice under section 41JA to provide the requested information within a further 10 working days. Following cancellation of this ARTG entry, the sponsor has also not provided any relevant supply information, including a list of their customers to whom these face masks may have been distributed.
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 where there is a risk of blood or body fluid splash or spray. 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 reviewed and is considered complete in accordance with the requirements of the URPTG.
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