GranuFlo® & NaturaLyte®

Knowledgeable Dangerous Drug Lawyers

On March 29, 2012, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall of GranuFlo® and NaturaLyte®, dialysis products manufactured by Fresenius Medical Care (FMC). Use of these dialysis products has been linked to an increase in the risk of cardiopulmonary arrest and sudden cardiac death. The manufacturer, FMC, was aware of the injuries and dangers associated with their dialysis products but failed to warn patients and doctors until 2012, placing more than half of all dialysis patients in the United States at risk. Now, people are reaching out to dangerous drug attorneys across the country to hold them responsible.

If you need to seek justice from these faulty manufactures, call (877) 958-7920.

Risks of GraunoFlo® & NaturaLyte® Injuries

The use of either GranuFlo® or NaturaLyte® can result in high bicarbonate levels that can cause metabolic alkalosis—a significant risk associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia, which may culminate in cardiopulmonary arrest and death. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences—or death.

Medical research links GranuFlo® and NaturaLyte® to high bicarbonate levels that can cause a variety of health problems including:

  • Cardiopulmonary arrest
  • Heart problems
  • Metabolic alkalosis
  • Low blood pressure
  • Sudden myocardial infarction or heart attack
  • Stroke
  • Death

The GranuFlo® and NaturaLyte® recall states that the company failed to disclose vital information to the FDA and health-care providers about the possible risk of high bicarbonate levels when administering these products. There are currently more than 5,700 dialysis centers providing service to approximately 400,000 dialysis patients in the United States. FMC, the largest dialysis services and products company in the U.S. and the world, not only owns thousands of dialysis clinics, it also manufactures nearly all the medical products used in dialysis care.

Holding These Manufacturers Responsible

If you or your loved one experienced any of these symptoms while undergoing dialysis, it is important to know you are legally entitled to seek justice. At Shrader & Associates L.L.P., our dangerous drug attorneys can guide you through the process of evaluating your claim and filing a lawsuit.

Reach Out to Shrader & Associates L.L.P. for a free consultation to discuss your options for legal recourse.

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