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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).
To resolve this issue, Aspen Medical is providing a leaflet with the "Important information about Aspen Medical Pty Ltd respirators" summarized within each box of impacted respirators.
The content of the leaflet associated with each Aspen Medical respirator subject to a Product Defect Alert (TGA recall action reference number: RC-2021-RN-00980-1) is provided below.
Leaflet
Important information about Aspen Medical Pty Ltd respirators (face masks)
Summary
- This mask is a public respirator that complies with >95% particulate filtration efficiency (PFE).
- This respirator is not sterile. DO NOT use this respirator if you need a sterile/surgical respirator.
- This respirator does not provide protection from liquid splashes (eg: blood or other bodily fluids). If you need protection from liquid splashes, use with a face shield or use a surgical respirator.
Importance of a proper fit
For a respirator to provide enough protection, ensure there is a seal between the facepiece of the respirator and the face of the wearer.
More details about respirator fit tests and checks are available in:
- AS/NZS1715:2009 - Selection, use and maintenance of respiratory protective equipment, Section 8
- Australian Guidelines for the Prevention and Control of Infection in Healthcare, Section 3.2.4
Sponsor details
The sponsor for this respirator is:
Aspen Medical Pty Ltd
Suite 17C 2 King Street,
Deakin, ACT, 2600, Australia
Batch details
Please see the following link for a list of batches for each respirator:
Product details
The preceding information is applicable to the following seven (7) public respirators:
| ARTG 335541 | ||
|---|---|---|
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
Xinxiang Kangming Hygienic Materials Development Co Ltd Dingluan town Industrial Zone Changyuan City; China | April 2020 | April 2022 |
| ARTG 335542 | ||
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
ESound Medical Device Co Ltd High-Tech Medical Equipment Industrial Park; China | April 2020 | April 2022 |
| ARTG 335653 | ||
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
Xinxiang Hongda Eucalyptus Co Dingluan Town Industrial Zone; China | April 2020 | April 2022 |
| ARTG 337175 | ||
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
Henan Yadu Industrial Co Ltd No 234 Jianpu West Road Changyuan County; Xinxiang City Henan Province 453400; China | May 2020 | May 2022 |
| ARTG 337536 | ||
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
Jiangmen Shuermei Medical Supplies Co Ltd Jingshuiwan Chakeng Village Committee Huicheng Town Xinhui District; Jiangmen City Guangdong; China | April 2020 | April 2022 |
| ARTG 337537 | ||
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
Improve Medical (HuNan) Co Ltd No 6 Yizhang East Avenue Economic Development District; Yizhang Hunan 4242000; China | April 2020 | April 2022 |
| ARTG 340222 | ||
| Manufacturer name and location | Date of Manufacture | Date of Expiry |
Shaoyang Qiankangyi Medical Instruments Co Ltd National Highway 320 Lianqiao Town; Shandong City Hunan Province; China | April 2020 | April 2022 |