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French authorities remain confident over Hospal dialyser

This article was originally published in Clinica

Executive Summary

The French healthcare product safety agency, AFSSAPS, has issued a precautionary statement concerning the Arylane M9 dialyser made by Hospal, a subsidiary of the Swedish manufacturer, Gambro. The product was withdrawn in Spain (see Clinica No 1003, p 3) following adverse events involving the filters. The French authorities state that as the problems have been linked to a single batch of the product. Since no products from this batch have been sold on the French market, and as the product has been used without incidents in France for a year, no withdrawals are necessary, it says. Hospal has sent a circular to those healthcare professionals whose departments have received these products.





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