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GranuFlo Recall

GranuFlo is a concentrated powder used by thousands of dialysis centers around the United States for kidney hemodialysis. The product allows clinics to mix their own dialysate on site, eliminating the need for massive and expensive liquid solutions.

Unfortunately, both the GranuFlo and NaturaLyte dialysis products made by German company Fresenius Medical Care (FMC) have been linked to increased risks of heart problems.

In March of 2012, the FDA issued a Class I Granuflo Recall after learning that FMC hid data showing safety risks of the product. Such health problems include:

  • Cardiopulmonary arrest
  • Low blood pressure
  • Stroke
  • Metabolic alkalosis
  • Heart attack and
  • Death

While the Granuflo recall does not require FMC to remove the product from the market, the company has changed warning labels to alert consumers. However, experts fear that thousands of patients may have been affected.

If you or a loved one suffered cardiopulmonary arrest, heart attack or death after dialysis treatment with Granuflo, it is important to speak with a lawyer about your legal options. Contact us today.

Fresenius Medical Care is the largest operator of dialysis clinics and supplier of dialysis products in the world. The recent Granuflo recall could affect more than a third of the 400,000 patients who require kidney dialysis in the United States each day.

The recall stems from a year-long study FMC conducted at more than 1,000 of its own clinics in 2010 due to concerns over the rate of heart problems among patients. The study revealed that 941 patients during that time suffered cardiopulmonary arrest, a rate six times the normal level.

In November of 2011, FMC alerted doctors at its own clinics of the risks of Granuflo, but failed to warn other clinics using their products, as well as the FDA and consumers. Instead, they continued to heavily market and sell Granuflo for patient use.

Only after an anonymous source forwarded the FMC internal memo to the FDA were they made aware of the dangers of Granuflo. FMC responded quickly by adding warning labels to the product, which was designated a Class I Granuflo Recall in March of 2012.

As a result of FMC’s attempts to hide the dangers of Granuflo, hundreds of thousands of dialysis patients were put at risk. Lawyers are currently helping families affected by cardiac arrest, heart attack or death from Granuflo file claims for their loss.

Due to the volume of lawsuits expected, a federal panel is in the process of consolidating Granuflo lawsuits to a special Multi-District Litigation court. A lawyer can explain the current litigation, as well as whether your case may qualify and how long you have to take action.

Before choosing a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The DrugRisk Resource Center only recommends law firms that specialize in medical device injuries and have handled Granuflo claims.

For more information on the warnings, recall and legal action related to Granuflo, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.