PRESS RELEASE: A Warning to all Australians

LifeVac Australia is an Australian-owned company that is the sole authorised, legal importer and distributor of the genuine LifeVac® Airway Clearance Device, a device that has already saved over 2500 lives (including over 1600 children) after first aid has failed and all without any harm. The genuine LifeVac® is listed on the Australian Register of Therapeutic Goods (ARTG #285082) as a Class 1 medical device as required under law, is compliant with all the TGA requirements for safety, and has been subjected to an extensive post-market, evidence, and clinical review. The genuine LifeVac® is only sold by LifeVac Australia through its website www.lifevac.net.au and its authorised agents, which are listed on the website.

LifeVac Australia has been very concerned about the growing number of illegal, dangerous, counterfeit (LifeVac copycat) devices being sold on e-commerce and social media sites in Australia, that are being manufactured in China. These same dangerous, counterfeit devices are subject to an urgent public recall alert by the device regulator in the UK (MHRA) due to the high risk to public safety if these fakes were trusted in an emergency. Evaluation of these counterfeit devices has shown very poor manufacturing quality; the complete absence of a one-way valve to prevent forcing objects down the airway; the malfunction of the device in an emergency; failure to create any or sufficient negative pressure; or the device simply falling apart when used.

Australians need to be aware, that these counterfeit, unsafe copies of LifeVac medical devices are being sold to Australians cheaply, but none have met any safety or effectiveness standards or undergone any tests or scientific studies. Australians should therefore exercise extreme caution in shopping for medical devices and only buy the genuine LifeVac Airway Clearance Device directly from our website or a listed authorised re-seller.

LifeVac Australia calls on the TGA to immediately take action to protect the lives of Australians including issuing an urgent public alert like the UK Medical Devices Regulator (MHRA), warning about the real danger of death or serious harm that can result from purchasing and using one of these counterfeit and illegal devices.

https://www.gov.uk/drug-device-alerts/counterfeits-and-unbranded-copies-of-lifevac-anti-choking-devices-may-fail-to-work-correctly-or-worsen-choking-incidents-if-used-dsi-slash-2024-slash-003
https://www.gov.uk/product-safety-alerts-reports-recalls/product-recall-counterfeit-anti-choking-devices-2405-0111?mkevt=1&mkdid=4&mkcid=30&bu=44477204823&trkId=143851343008
Written and authorised by S Gould Owner/Director LifeVac Australia