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MHRA: Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used

Summary

Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or CE mark and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant.

Content

The MHRA is aware of numerous unbranded and counterfeit anti-choking devices (also known as airway clearance devices, choking rescue devices, or emergency first aid devices) which do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) being sold online via marketplaces and drop-shipping websites.

The MHRA is currently aware of only two anti-choking device brands, LifeVac and Dechoker, which have a valid UKCA or CE mark and are registered with the MHRA in accordance with the UK MDR 2002. Both of these brands are intended to be used only after established Basic Life Support protocols (back slaps, abdominal thrusts) have been attempted and failed. There is further information and guidance on anti-choking devices available.

The vast majority of counterfeit and unbranded anti-choking devices, primarily originating from China, appear similar or identical in design to the LifeVac anti-choking device and, in some cases, may claim to be this brand.

Use of a counterfeit or unbranded anti-choking device carries a significant risk of failure to work, and may even worsen the situation by further pushing obstructions down the airway passage due to their poor design and quality.

Image comparison between genuine and counterfeit anti-choking devices is provided on the MHRA website from the link below.

MHRA: Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly o… https://www.gov.uk/drug-device-alerts/counterfeits-and-unbranded-copies-of-lifevac-anti-choking-devi…

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