The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not comply with device regulations and could cause harm.
It is estimated that over 10,000 counterfeit or unbranded anti-choking devices, also known as airway clearance devices, choking rescue devices or emergency first aid devices, have been purchased by the public within the last two years based on listings found across online marketplaces like Amazon and eBay, and drop-shipping websites.
There are currently two anti-choking device brands, LifeVac and Dechoker, which have a valid UKCA or CE mark and are registered with the MHRA to be used after Basic Life Support protocols have been attempted and failed. Use of a counterfeit or unbranded anti-choking device carries a significant risk of failure to resolve the blockage and may worsen the situation by pushing obstructions further down the airway passage.
A product comparison with photos highlighting the differences between a genuine and a counterfeit device can be found in our Device Safety Information alert.
MHRA guidance on buying medical devices advises the public to exercise caution when purchasing these products online and to ensure that they are purchased from reputable sellers. People should be particularly vigilant for sites using fake reviews to promote their product and should also check to see that the device manufacturer is registered with the MHRA via the public access database.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Patient safety is our top priority. Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements.
These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents.
The MHRA is working with online marketplaces to remove unbranded and counterfeit anti-choking devices from sale. Do not use the device if you suspect it is counterfeit. Please submit a Yellow Card report if you have previously used a counterfeit or unbranded device and it failed to work, including details of where you bought the product.
The majority of counterfeit or unbranded anti-choking devices are manufactured or shipped from China, appear in a similar or identical design to the LifeVac anti-choking device and, in some cases, claim to be the genuine brand.
None of the anti-choking devices registered with the MHRA are manufactured in China. Any products shipped from China should be treated with caution and disposed.
If anyone is uncertain about whether their device is genuine or a counterfeit, contact the legal manufacturer, LifeVac, and report the incident regarding the product to the Yellow Card scheme.
Notes
- The legal manufacturer, LifeVac, can verify the legitimacy of a purchased product against their records of authorised distributors and product serial numbers.
