FDA Warns Fresenius Medical Over Dialysis Device

Law360, New York (March 14, 2013, 8:09 PM EDT) -- Fresenius Medical Care North America said Thursday that it had received a warning letter from the U.S. Food and Drug Administration over its artificial kidneys, also known as dialyzers, which are used in dialysis machines to filter a patient's blood.

The FDA's warning letter claims that Fresenius did not do adequate studies to make sure the dialyzers match their design, the company said. The FDA stated that "the organization did not conduct adequate design verification studies of its electron beam sterilized polysulfone dialyzers manufactured" and that...
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