FDA GranuFlo Recall

The FDA has issued a class one recall on dialysis product GranuFlo and Naturalyte, indicating that these concentrates can cause serious adverse health consequences or death.  The FDA has recalled these products, which are used during hemodialysis procedures in patients with acute or chronic renal failure, because they can put patients at risk for sudden cardiac arrest.  It has been argued that the manufacturer, Fresenius Medical Care, knew about this risk of cardiac arrest, yet failed to immediately warn the dialysis centers that were using GranuFlo and Naturalyte.

The primary problem with GranuFlo is that it contains more bicarbonate than similar, rival products.  As a result, the appropriate prescription is essential.  However, GranuFlo, due to its additional level of bicarbonate, has been difficult for physicians to determine how much of the substance should be administered, leaving patients prone to heart problems.  High serum bicarbonate levels can contribute to a metabolic condition known as metabolic alkalosis, which can put a patient at risk for low blood pressure, cardiac arrhythmia, low blood oxygen pressure, low potassium levels in the blood, and high concentration of carbon dioxide in the blood, which can ultimately lead to cardiac arrest and death.

We are currently investigating and handling cases for individuals or family members that have suffered cardiac arrest or death after using GranuFlo or Naturalyte while on dialysis.  If you have a family member that was on dialysis and had any sort of heart condition, please contact David Grebel Law today at (314) 221-0559 for further details.

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