GranuFlo and NaturaLyte Recall Due to Association with Cardiac Arrest

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GranuFlo and NaturaLyte Recall Due to Association with Cardiac Arrest

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GranuFlo Heart Attack and NaturaLyte Heart Attack Risk

GranuFlo and NaturaLyte, drugs used in many dialysis centers across the United States, have been recalled by the U.S. Food and Drug Administration (FDA). According to the FDA, the products have been linked to heightened levels of bicarbonate, a contributing factor in cardiac arrest. Some cardiovascular events patients are at risk for include:

Low blood pressure
Cardiac arrhythmia
Stroke
Cardiopulmonary arrest
Sudden heart arrest
Heart Attack
Death

The recall of GranuFlo and NaturaLyte is a Class 1 recall. This type of recall is classified as the most severe and is issued in situations in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.

According to an internal memo released by Fresenius Medical Care, the manufacturer of GranuFlo, more than 900 patients using GranuFlo experienced cardiac arrest in 2010. Despite releasing the memo internally in late 2011, the FDA was not made aware of the results until May 2012.

FDA Medwatch released the following statement:

“FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. 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.”

Click here for more information from the FDA regarding the Class 1 recall of GranuFlo and NaturaLyte.

Dialysis Heart Attack Risk

If you were administered GranuFlo or NaturaLyte in your dialysis treatment, finding out if you have a potential claim is easy. If you call Longo Legal, PLLC, we can walk you through it. The first step is to get some preliminary information over the phone. The initial phone call and consultation cost you nothing. You will not pay Longo Legal, PLLC anything towards your Granuflo or NaturaLyte lawsuit unless a recovery is made on your behalf. Call Longo Legal at (855) 566-4648 to see if you qualify.

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