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29 March 2024

UAE bans sale of two medical products

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By Staff

The Ministry of Health has banned the sale and use of two medical devices, one made by a British company that is used in kidney dialysis and the other a US-made lung-sealant system used in post-surgical procedures.

They were withdrawn from the market due to non-conformity of international standards in their quality, Al Ittihad reported.

In a notification issued on Sunday by Dr. Amin Amiri, Executive Director of the Medical Practice and Licensing, the ministry informed that the Medicines and Healthcare Products Regulatory Authority reported a defect in the manufacturing of bloodlines used in haemo dialysis.

The product made by British company Fresenius Medical Care AG Co. comes with the batch number 5008/5008S E-beam and 4008 ETO.

Inconsistency in the material used in the connectors of the pipe could lead to reduced stiffness and thereby making it difficult to connect to pipes made by other companies. This may lead to leakage of blood among other problems, the notification said.

The US-based pharmaceutical company Covidien has voluntarily withdrawn its Pleura Seal lung-sealant system after evaluations done in the US. The tests carried out indicated that the product may lead to complications in patients who undergo lung surgery.

The ministry circular urged medical practitioners to follow the instructions and contact the Drug Control Department on 02-6117391 / 6117642 for any clarifications.