Product Recall: Counterfeit Anti-Choking Devices (2405-0111)
Product recall for counterfeit anti-choking devices sold via Amazon, eBay, AliExpress, Alibaba, Fruugo, OnBuy, Facebook Marketplace and DesertCart presenting a risk of choking.
Summary
Product: Counterfeit anti-choking devices sold via Amazon, eBay, AliExpress, Alibaba, Fruugo, OnBuy, Facebook Marketplace and DesertCart.
Hazard: The product may present a risk of choking as they may not work, and could worsen the situation by further pushing obstructions down the airway passage due to their poor design and quality.
Corrective action: The product has been recalled from end users by Amazon. The listings have been removed by Amazon, eBay, AliExpress, Alibaba, Fruugo, OnBuy, Facebook Marketplace and DesertCart.
Product information
| Type | Medical Device - Anti-Choking Device |
|---|---|
| Product Identifiers | Counterfeit and unbranded copies lack UKCA / CE mark, details of the manufacturer, UDI and serial numbers on the device |
| Country of Origin | China |
| Product Description | Yellow and clear plastic counterfeit anti-choking device intended to alleviate choking incidents. The plastic colour may vary in unbranded copies. There is no CE or UKCA marking. |
| Product Report and Image |
Hazard
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed.
Counterfeit and unbranded anti-choking devices 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.
Counterfeit and unbranded anti-choking devices appear similar in design to the genuine LifeVac anti-choking device, and primarily originate from China. No genuine anti-choking devices marketed in the UK are manufactured in China.
Use of a counterfeit or unbranded anti-choking device carries a significant risk of failure to work, and may worsen the situation by further pushing obstructions down the airway passage due to their poor design and quality.
Additionally, the instructions supplied with the product do not sufficiently communicate the warnings, steps and considerations to take into account for appropriate and safe use of these devices.
The counterfeit products do not meet the requirements of the UK Medical Device Regulations 2002 or the General Product Safety Regulations 2005.
Corrective action
The product has been recalled from end users by Amazon, and customers notified.
Listings have been removed by the following online marketplaces: Amazon, eBay, AliExpress, Alibaba, Fruugo, OnBuy, Facebook Marketplace and DesertCart
Owners should check that your anti-choking device is genuine using the provided guidance.
Do not use the anti-choking device in the event of a choking emergency if you suspect that the device you have purchased is a counterfeit or unbranded copy of the legitimate LifeVac anti-choking device. Ensure that you dispose of counterfeit products safely.
Additional information
PSD case number: 2405-0111
Notified by: Medicines and Healthcare products Regulatory Agency (MHRA)