Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2021-RN-00930-1
Product Name/Description	GT Construction Australia - ARTG: 334303 Mask, Surgical, Single Use ARTG: 334303 - Cancelled by the Secretary - as of 07 December 2020
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	28/04/2021
Responsible Entity	GT Construction Australia
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(s) 334303 from the Register on the basis that GT Construction Australia failed to comply with a condition of inclusion for the Device in the ARTG. That condition is that you must have available, at all timeswhile the Device is in the ARTG, sufficient information to substantiate compliance with the Essential Principles (see section 41FN(3)(a)(i) of the Act). Following cancellation of these ARTG entries, the sponsors have 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; 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.
Contact Information	jenny_wu05@hotmail.com