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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00651-1
Product Name/Description	Mahoma Pro Protective Face Mask, 4 Ply Mask ARTG 341784 cancelled as at 18/10/2022
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/07/2023
Responsible Entity	Ridgeback Logistics
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) 341784 from the Register on the basis that Ridgeback Logistics failed to comply with the notice under section 41JA within a further 10 working days from the day specified in that notice. The TGA has not have received important information to determine whether these facemasks comply with the medical device essential principles or whether they are of satisfactory safety, performance, presentation or quality. 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	This action has been closed out on 17/07/2023
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