Granuflo and Naturalyte dialysis treatment products have been associated with cardiac arrests. At one time, Fresenius Medical Care, a German based company, owned and operated the most kidney dialysis centers in the country. The company treated more than a third of the 400,000 Americans receiving dialysis for chronic and acute renal failure.
On November 4, 2011, Fresenius sent an internal memo reporting that more than 900 patients had experienced heart attacks in Fresenius clinics during the previous year. The memo linked Granuflo use to increased levels of bicarbonate, which increases by six times the likelihood of having a cardiac arrest. Fresenius warned its own doctors but did not warn outside clinics which used its products until the FDA was leaked the internal memo.
On March 29, 2012, a Class I recall was issued on Granuflo and Naturalyte concentrations that were manufactured and distributed between January 2008 and June 2012. According to the FDA, a Class I recall is the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. More then 1,500 Granuflo and Naturalyte lawsuits have been filed and trials are expected shortly.
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