New York City GranuFlo and Naturalyte Defective Drug Lawyers


FDA Issues Class I Recall of GranuFlo and Naturalyte

On March 29, 2012 the FDA issued a Class I recall of Naturalyte and Granuflo Acid Concentrate dialysis products manufactured by Fresenius Medical Care. As part of the recall, the FDA now believes there is a reasonable probability that use of GranuFlo and Naturalyte products will lead to severe adverse health consequences and may even lead to death.

Additionally, there has been a general safety communication issued by the FDA regarding the inappropriate prescriptions of GranuFlo and Naturalyte. These prescriptions have resulted in large alkali dosing errors in GranuFlo and Naturalyte.

What Is GranuFlo and Naturalyte?

GranuFlo and Naturalyte are products manufactured by Fresenius Medical Care. Fresenius Medical Care is responsible for the treatment of nearly 150,000 Americans who receive dialysis. Fresenius is also a leading supplier of disposable products and dialysis machines in the United States.

Specifically, GranuFlo and Naturalyte are drugs used during dialysis that are designed to help maintain the appropriate balance of acidity to alkalinity in the bloodstream of patients. GranuFlo is one of the most-widely prescribed dry acid dialysis products in the industry.

What Are the Side-Effects of GranuFlo and Naturalyte?

The use of GranuFlo and Naturalyte has been shown to cause a high serum bicarbonate level in hemodialysis patients. High bicarbonate levels can substantially increase risks for the following:

  • Cardiac arrest
  • Low blood pressure
  • Cardiac arrhythmia
  • Low blood oxygen pressure
  • Low potassium levels in the blood
  • High concentration of carbon dioxide in the blood
  • Metabolic alkalosis

Cardiopulmonary Arrest caused by GranuFlo and Naturalyte

After nearly 1,000 cases of cardiac arrest linked to GranuFlo and Naturalyte were reported to the manufacture, Fresenius, an investigation was conducted to determine the correlation between the drug and patient related incidents. According to an internal memo released by Fresenius Medical Care in November 4, 2011, the investigation found that there were 941 instances of cardiopulmonary arrest at 667 different Fresenius facilities between January 1, 2010 and December 31, 2010.

If you believe that you suffer from injuries as a result of the use of the drug GranuFlo or Naturalyte, contact the defective drug team at Finz & Finz, P.C., now toll free at (855) TOP-FIRM or simply complete the Free GranuFlo/Naturalyte Drug Injury Case Evaluation form to find out how Finz & Finz, P.C., can help you.