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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00285-1
Product Name/Description	Sunry Health Management Pty Ltd Mask, surgical, single use ARTG: 341697 - Sunry Health Management Pty Ltd - Mask, surgical, single use- Cancelled by Secretary 9/2/2022
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	11/04/2023
Responsible Entity	Sunry Health Management 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 ARTG number 341697 from the register. 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 closed out on 25/10/2023
Contact Information	tiffy@sunryhealth.com