6/19/2013 8:46:20 AM
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After the FDA announced a Class I recall of dialysis products GranuFlo and NaturaLyte in June 2012, Fresenius Medical Care became associated with health care concerns around the country, particularly sudden heart attack and death. Now, the company is in the news again. On March 5, 2013, the FDA sent the company a warning letter concerning another dialysis product, stating that the validation process was incomplete. Fresenius Warned About Dialyzers: The warning letter concerned the FDA’s inspection of Fresenius’ Ogden, Utah manufacturing plant. Fresenius produces the Optiflux Polysulfone Dialyzers there, which are so-called “artificial kidneys.” During hemodialysis—a procedure in which the kidney patient’s blood is run through a machine to clean it of waste and toxins—the blood is filtered through a man-made membrane called a dialyzer, and then returned to the body.
- See more at: http://newyork.legalexaminer.com/fda-and-prescription-drugs/granuflo-manufacturer-fresenius-receives-fda-warning-letter.aspx?googleid=309084#sthash.SKMH4dFg.dpuf
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