Biomed Middle East

Poundworld Sentenced For Sale Of Defective Medical Devices, UK

Discount retailer, Poundworld Retail Ltd, was fined £5,000 and ordered to pay costs of £9,000 for selling defective digital thermometers and other non-compliant medical devices to the UK market.

The defective thermometers, which were found to give an inaccurate reading, were discovered in several shops across the UK following an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) last year.

Despite being issued with formal notices, the company continued to place the products onto Poundworld shelves after being told by MHRA Compliance Inspectors to remove them from the market.

The defective thermometers were not CE marked, which determines compliance with UK legislation, and they were not accompanied by the appropriate warnings, precautions and instructions for use.

Additionally, the packaging did not supply information on the manufacturer, or the batch, or serial number.

A number of other non-compliant devices were discovered including bandages, plasters and sterile dressings.

MHRA Director of Devices Peter Commins said, “By knowingly placing these products onto the market, Poundworld has shown a severe disregard for public health.

“The defective thermometers are not compliant with UK legislation, meaning there is no assurance that they meet appropriate standards of safety and performance.

“The MHRA will continue to take action against individuals who put public health at risk.”

Source: MHRA

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