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Type of Product	Medical Device
TGA Recall Reference	RC-2021-RN-01312-1
Product Name/Description	Detmold Medical D95+ Surgical Respirator Masks Batch numbers: 79046574, 79046575, 79030656, 79039278, 79046270, 79034858, 79035536, 79046290, 79035513, 79036932, 79040947, 79035535, 79035326, 79029524 ARTG 337768 (Detmold Medical Pty Ltd - Surgical/medical respirator, single-use).
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/06/2021
Responsible Entity	Detmold Medical 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). Detmold Medical has supplied a number of 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. This action was undertaken prior to TGA notification. The TGA has cancelled the Device with ARTG number 337768 from the Register at the sponsors request, as of 23 June, 2021.
Recall Action	Recall
Recall Action Instructions	Customers are advised to immediately quarantine and return goods to the Sponsor or destroy goods on site. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	08 8348 3847 - Detmold Medical