GranuFlo FDA RecallThe U.S. Food and Drug Administration (FDA) has issued a Class 1 recall of the GranuFlo and Naturalyte dialysis products, manufactured by Fresenius Medical Care. The problem is that the products contain a chemical that converts to bicarbonate, which may cause a deadly bicarbonate overdose if a physician is not very careful with the dose. The FDA recall follows a report that 941 people suffered cardiac arrest at Fresenius clinics in 2010.

 

Do I Have a GranuFlo Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by GranuFlo or Naturalyte dialysis products, you should contact our lawyers immediately. You may be entitled to compensation by filing a GranuFlo lawsuit.

GranuFlo FDA Recall

May 25, 2012 — The dialysis products GranuFlo Dry Acid Concentrate and Naturalyte Liquid Concentrate have been recalled by the FDA. According to the FDA Safety Communication:

Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

GranuFlo and Naturalyte are manufactured by Fresenius Medical Care, a German-based company that owns most of the dialysis clinics in the United States. The company also produces many products used in dialysis treatment. The recalled products were used from January 2008 until they were pulled from the market in June 2012.

A Class 1 recall is the FDA’s most urgent recall, reserved for products or devices that have a high probability of causing severe injury or death.

Why did the FDA Recall GranuFlo?

GranuFlo and Naturalyte were recalled because they can cause severe injury, cardiac arrest, heart attack, stroke, or death. The problem is that health care professionals may not be aware than an ingredient in GranuFlo converts to bicarbonate in a patient’s body. This can cause a deadly bicarbonate overdose.

Dialysis is a process in which a patient with kidney failure has their blood removed, mechanically cleaned of toxins, and re-injected into their body. Acid normally builds up during this process. To neutralize the acid, health care professionals usually add bicarbonate, an alkaline substance. GranuFlo and Naturalyte are also used to balance the acidity and alkalinity of the body. Most acid-concentrate products consist primarily of acetic acid. GranuFlo and Naturalyte consist of acetic acid plus acetate. The problem is that the acetate is rapidly converted to bicarbonate by the patient’s liver. This causes bicarbonate levels to increase beyond what the physician initially prescribed. If the health care professional does not adjust the dosage to compensate for the added bicarbonate, the patient may suffer a deadly bicarbonate overdose.

GranuFlo Recall and Failure to Warn

GranuFlo and Naturalyte are associated with elevated bicarbonate levels, a risk factor for sudden cardiac arrest and death. Fresenius first became aware of the problem in 2011, when medical staff noticed a sharp increase in the number of patient deaths at Fresenius clinics — in 2010, there were 941 cardiac arrests at 667 Fresenius clinics. Fresenius found that patients with high bicarbonate levels were six-times more likely to have a sudden cardiac arrest.

On November 4, 2011, Fresenius sent a memo to doctors at their clinics, warning about the risk of deadly bicarbonate overdose associated with GranuFlo and Naturalyte. This memo was not sent to the FDA or doctors at other clinics.

The FDA only became aware of the problem after someone anonymously sent a copy of the memo. When the FDA questioned Fresenius, they quickly agreed to publish an Urgent Safety Notification. They later agreed to a voluntary Class 1 recall of the GranuFlo and Naturalyte.

Fresenius is now facing numerous product liability lawsuits from people who allege that the company failed to warn about the life-threatening risks of GranuFlo and Naturalyte.

Do I have a GranuFlo Lawsuit?

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