Important information about Aspen Medical Pty Ltd respirators (face masks): Batches

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of all face masks included in the Australian Register of Therapeutic Goods (ARTG) to ensure the quality and effectiveness of face masks supplied in Australia, including that they meet the legislative requirements for medical devices, and perform as intended.

For information about the review, including guidance for suppliers and users of face masks, see Face masks and COVID-19.

Aspen Medical has supplied a number of respirators on the ARTG with missing or incomplete labelling information (including batch numbers, date of expiry and/or manufacturers' names).

The below table lists the relevant ARTG number, manufacturer name, batch numbers and expiry date associated with each Aspen Medical respirator subject to a Product Defect Alert (TGA recall action reference number: RC-2021-RN-00980-1).