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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00573-1
Product Name/Description	MA-KN95-WOO Batch numbers: QU201 and QU202 Expiry date: 05/2022 and 06/2022 ARTG 333698 - Cancelled as of 04/07/2021
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	4/04/2022
Responsible Entity	Omni-Tel 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). Omni-Tel Pty Ltd has supplied two batches of MA-KN95-WOO respirators which, when tested by the TGA, demonstrated inconsistent testing results for fluid resistance and Particulate Filtration Efficiency (PFE).
Recall Action	Recall
Recall Action Instructions	Customers are advised to immediately quarantine and discontinue use of affected product.
Contact Information	TBC