GranuFlo Class 1 Recall

GranuFlo Class 1 Recall

Posted By The Maher Law Firm || 11-Feb-2013

GranuFlo is one part of a three part dialysate procedure used during dialysis.

Dialysis is a process in which toxic waste is removed from the bloodstream by neutralizing acids that build up in the blood – basically replacing the function of the kidneys. GranuFlo and NaturaLyte (another dialysis product) were issued a class 1 recall by the FDA (Food and Drug Administration) in June of 2012. A class 1 recall is the most serious level of recall that can be ordered by the FDA.

GranuFlo and NaturaLyte are manufactured by Fresenius USA – the largest operator of hemodialysis clinics in the United States and the leading supplier of dialysis machines and products. Roughly 400,000 dialysis patients receive their treatment from Fresenius – nearly 950 people suffered cardiac arrest at a Fresenius facility in 2010 alone.

Since GranuFlo and NaturaLyte both use sodium diacetate – which doubles the amount of acetate in dialysate, they cause the total “buffer” level to be higher than the bicarbonate level delivered from bicarbonate concentrate, which in turn, causes the production of too much bicarbonate, causing serious side effects such as cardiac arrest and sudden death.

When the FDA informed Fresenius that their warnings regarding the risks of their products were not strong enough, Fresenius, allegedly informed their own doctors and clinics about the problems with GranuFlo and NaturaLyte but did not inform dialysis treatment centers that were not under their control, leaving thousands of dialysis providers uninformed as to the possible side effects.

Currently there are GranuFlo and NaturaLyte lawsuits targeting Fresenius for either not being aware of their drug’s side effects, or possibly withholding the necessary information from doctors and clinics.

Patients or the families of those who have suffered cardiac arrest or heart attack due to GranuFlo and/or NaturaLyte distributed by Fresenius Medical Care may be entitled to compensation.

You have the right to trust your medication is safe. Tragically, this is not always the case. Victims however, may recoup damages through a successful product liability claim against the drug's maker. Well versed in product liability laws that protect consumers, our GranuFlo and NaturaLyte attorneys have handled countless lawsuits involving harmful pharmaceuticals. If you have experienced GranuFlo and/or NaturaLyte side effects, contact us today to discuss your potential case.

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