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Type of Product	Medical Device
TGA Recall Reference	RC-2021-RN-02335-1
Product Name/Description	Perios Pty Ltd - KN95 Particulate Respirator Lot number:20200402 ARTG 335041 (Mask, surgical, single use - Cancelled as of 27/11/2020)
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	2/12/2021
Responsible Entity	Perios 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). Perios Pty Ltd has supplied respirators which have shown inconsistent testing results, specifically for Particulate Filtration Efficiency (PFE), which measures the efficiency of the respirator to filter fine particles from inspired air. Respirators which perform below the claimed level of PFE will not afford their wearers the expected level of protection when used in an environment where respiratory protection is required. Samples provided to the TGA were also missing labelling requirements applicable to the goods, including: manufacturer name and address, batch numbers, expiry dates, storage conditions, labels indicating ‘not for medical use’ and labels indicating ‘single use’.
Recall Action	Recall
Recall Action Instructions	Customers are advised to isolate and destroy any remaining stock on site. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	0401 950 733 - David French (Perios)