A request has been sent by the FDA to Fresenius Medical Care. In the request, the government agency is asking the the maker Naturalyte Liquid Concentrate and Naturalyte GranuFlo Acid to issue a recall on the aforementioned hemodialysis products following reports of alkali dosing errors. Prior to the request, the company was under investigation by the same government regulating body for its failure to promptly issue a public warning of serious risks connected to the subject kidney dialysis products. The dosing error on GranuFlo could result to heart attack, stroke or some other problems that could be considered fatal. A recall on Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo were initiated in June 2012, prompting lawyers to look into the probability of a Granuflo lawsuit. In fact, some personal injury law firms have already prepared for the impending legals battles that may occur following the recall that some of them, like the Rottenstein Law Group of New York, has put up online lawsuit information centers, like its rotlaw.com, to offer free legal help to those who felt affected by the subject products. Manufactured and distributed in January 2008 all through June 2012, Naturalyte and GranuFlo were developed by Fresenius as chemical components in treating acute and chronic renal failure in hemodialysis procedures. The formulation of the concentrate is meant to be used for a three-stream hemodialysis machine. As per FDA safety recall that began in March 2012, machines to which the subject products are used were calibrated for acid and bicarbonate concentrates. Acetic acid and sodium acetate, which are both used by GranuFlo and NaturaLyte, can lead to added presence of sodium acetate in the dialysate. In turn, these chemicals can cause heightened bicarbonate levels in the bloodstream. High levels of bicarbonate cause Granuflo side effects such as cardiopulmonary arrest, cardiac arrest, stroke, metabolic alkalosis, low blood pressure and even death. On November 4, 2011, Fresenius issued an internal memo. The memo was meant to warn its doctors working in Fresenius dialysis clinics that the GranuFlo and NaturaLyte products could cause a greater risk of cardiac arrest and other heart problems. The memo was anonymously leaked to the FDA earlier this year. Records show that there were 941 dialysis patients who suffered cardiac arrest in 2010 resulting from GranuFlo use. Dangerous levels of bicarbonate could risk the company’s patients to cardiac arrest with a chance of up to six times higher than those who are using competing products. Unfortunately, such warning was kept within company confines and was only released to the general public in March 2012. The legal community is on alert and is putting up websites, such as those of New York based Rottenstein Law Group, as it is investigating the possibility of a lawsuit against Fresenius involving Granuflo for dialysis patients affected by Granuflo dosing errors.
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