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

Important safety information on Aspen Medical respirators, including labelling issues, proper use, and limitations identified during a TGA post‑market review.

Published

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

ppeprocurement@aspenmedical.com

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 locationDate of ManufactureDate of Expiry

Xinxiang Kangming Hygienic Materials Development Co Ltd

Dingluan town Industrial Zone Changyuan City; China

April 2020April 2022
ARTG 335542
Manufacturer name and locationDate of ManufactureDate of Expiry

ESound Medical Device Co Ltd

High-Tech Medical Equipment Industrial Park; China

April 2020April 2022
ARTG 335653
Manufacturer name and locationDate of ManufactureDate of Expiry

Xinxiang Hongda Eucalyptus Co

Dingluan Town Industrial Zone; China

April 2020April 2022
ARTG 337175
Manufacturer name and locationDate of ManufactureDate of Expiry

Henan Yadu Industrial Co Ltd

No 234 Jianpu West Road Changyuan County; Xinxiang City Henan Province 453400; China

May 2020May 2022
ARTG 337536
Manufacturer name and locationDate of ManufactureDate of Expiry

Jiangmen Shuermei Medical Supplies Co Ltd

Jingshuiwan Chakeng Village Committee Huicheng Town Xinhui District; Jiangmen City Guangdong; China

April 2020April 2022
ARTG 337537
Manufacturer name and locationDate of ManufactureDate of Expiry

Improve Medical (HuNan) Co Ltd

No 6 Yizhang East Avenue Economic Development District; Yizhang Hunan 4242000; China

April 2020April 2022
ARTG 340222
Manufacturer name and locationDate of ManufactureDate of Expiry

Shaoyang Qiankangyi Medical Instruments Co Ltd

National Highway 320 Lianqiao Town; Shandong City Hunan Province; China

April 2020April 2022

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