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FDA GranuFlo Recall for Residents

GranuFlo FDA Warning

Following its receipt of an internal Fresenius Medical Care memo alerting clinicians of the risk of heart attack associated with GranuFlo, the FDA acted promptly to warn medical professionals and consumers about the dangers associated with the medical product. A GranuFlo FDA Warning was issued on May 25, 2012 and a Class 1 Granuflo FDA Recall was released on June 27, 2012. Noting varying levels of the active ingredients acetate and sodium diacetate in dialysate products such as GranuFlo, the Granuflo FDA recall warns that these products can cause a condition called metabolic alkalosis in dialysis patients, which puts an individual at risk for heart conditions that, if left untreated, can progress to heart attack and even death.

Class 1 GranuFlo FDA Recall Warns of Heart Attack Risk

GranuFlo FDA RecallThe FDA has received reports of heart attack as a result of metabolic alkalosis after using GranuFlo. The GranuFlo FDA Recall warns that GranuFlo, “may cause serious adverse health consequences, including death”. Fresenius Medical Care is currently under investigation for a failure to communicate this vital medical information to the public, which may constitute a breach of federal regulations. This is a very serious accusation, in light of the fact that the concealed information was sufficient to prompt a Class 1 GranuFlo FDA recall.

The GranuFlo FDA Warning and Subsequent Class 1 GranuFlo FDA Recall are aimed at medical practitioners that oversee dialysis treatment. Dialysis treatment is a procedure that replaces the ordinary function of the kidneys, cleansing the blood of toxic waste. In addition to a dialysis machine, products known as dialysates are used to lower acidity in the blood. GranuFlo contains the active ingredients acetate and sodium diacetate which, when processed by the body, produce bicarbonate. If too much bicarbonate is produced, cautions the GranuFlo FDA Recall, the patient is at risk for developing alkalosis. Metabolic alkalosis can lead to the following heart conditiions:

  • Low Blood Pressure
  • Hypokalemia
  • Hypoexemia
  • Hypercapnia
  • Cardiac Arrhythmia

All of these heart conditions are in turn risk factors for cardiac arrest, or heart attack, if not treated promptly in an appropriate manner.

GranuFlo FDA Recall is Most Severe FDA Warning

Of all the types of medical recalls that are issued by the FDA, Class 1 recalls are reserved for the most dangerous medical products only. The FDA defines a class 1 recall as those that are, “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.”

Despite the GranuFlo FDA Recall, the product is still in use in the United States. In fact, Fresenius Medical Care operates more dialysis clinics than any other provider in the country, and is also the leading supplier of dialysis machines and other related products such as dialysates. The GranuFlo FDA recall urges extreme caution in the use of the product during hemodialysis.

Who is Affected by the GranuFlo FDA Recall?

The GranuFlo FDA Recall applies to any patient who has received hemodialysis treatment that utilized Fresenius Naturalyte GranuFlo or Liquid Acid Concentrate products and suffered at heart attack. Anyone who fits this description may be able to file a GranuFlo FDA recall lawsuit. To better understand whether you have grounds for a GranuFlo FDA recall lawsuit, contact our attorneys for a free consultation.