Fresenius Medical Care North America has recalled two of its GranuFlo products: NaturaLyte GranuFlo Acid Concentrate and NaturaLyte Liquid Acid Concentrate. An investigation led the U.S. Food and Drug Administration (FDA) to initiate a product recall.2
No GranuFlo class action lawsuits have taken place. But least one GranuFlo lawsuit has been filed alleging that a patient died as a result of using GranuFlo.3
Background on GranuFlo and NaturaLyte
Both NaturaLyte GranuFlo Acid Concentrate and NaturaLyte Liquid Acid Concentrate are dialysis products. Dialysis is a mechanical process doctors use to clean the blood when patients’ kidneys are not functioning.
Fresenius is the nation’s largest operator of dialysis centers, according to the New York Times.4
After discovering that these two products could increase the risk for cardiac arrest by a factor of six, Fresenius sent a warning memo to doctors practicing in its own dialysis centers. However, the company did not inform other doctors of the risks until the FDA pressured it to do so.4
The office that produced the warning memo was in Fresenius’ medical division. This division is unable to communicate directly with customers except by publishing research reports. The products division of the company could have communicated with customers but was hesitant to do so because the internal memo did not mention specific adverse events.4
Hazards and Risks of GranuFlo
GranuFlo contains an ingredient that the body converts to bicarbonate to neutralize acid in the blood. GranuFlo contains more of this ingredient than rival products do.4
According to the FDA, the high levels of bicarbonate produced by GranuFlo and NaturaLyte use can contribute to metabolic alkalosis.1 This may cause:
- Low blood pressure
- Low blood potassium levels
- Low oxygen levels in the blood
- High blood levels of carbon dioxide
- Irregular heartbeat
- Cardiac arrest
Blood oxygen levels may be measured in one of three ways: a low partial pressure of oxygen, a low content of oxygen, or a low percent saturation of hemoglobin with oxygen.
Find an Attorney for GranuFlo issues
If you or one of your relatives has experienced health problems due to NaturaLyte GranuFlo Acid Concentrate or NaturaLyte Liquid Acid Concentrate, you may be interested in contacting a personal injury lawyer who is familiar with GranuFlo lawsuits. Find a GranuFlo attorney today.