Why Were the Fresenius Dialysis Treatments GranuFlo and Naturalyte Recalled?
In March 2012, Fresenius Medical Care issued a warning about the risk of problems with Granuflo and Naturalyte, two acid concentrates used during dialysis treatments throughout the United States.
Due to inadequate warnings provided with these products and the serious risk of individuals suffering a cardiac arrest, heart attack or sudden death during dialysis treatment, the FDA classified these warnings as a recall for Granuflo and NaturaLyte.
Although dialysis clinics were not directed to immediately stop using the products or to return them, Granuflo and NaturaLyte were recalled for re-labeling and updated operating manuals were provided for dialysis machines.
Fresenius Recall Issued Due to Risk of Cardiac Arrest, Death from Granuflo, Naturalyte Dialysis Treatments
Granuflo is a dry acid concentrate and NaturaLyte is a liquid concentrate. The products were manufactured and sold by Fresenius Medical Care for use as part of the dialysate solution during hemodialysis.
The Fresenius products were recalled because of the risk of cardiovascular problems that may occur if bicarbonate buffer levels are not carefully monitored during treatment.
Do You Suspect an Injury from Recalled Fresenius Dialysis Treatments?
Granuflo and Naturalyte contain sodium acetate, which converts to bicarbonate at a higher level than most other dialysis treatment products.
As a result of the improper warnings and instructions provided by the manufacturer, hundreds of individuals have suffered catastrophic and often fatal injuries when their bicarbonate levels were increased beyond what was intended and prescribed by the doctor.
In November 2011, Fresenius sent an internal memo to physicians at their own dialysis treatment clinics, warning doctors to carefully monitor and adjust dialysate bicarbonate prescriptions. It also advised them to provide immediate attention to patients with dialysis bicarbonate levels of greater than 24 mEq/L.
However, Fresenius failed to provide these warnings to other dialysis treatment centers that used the Granuflo or Naturalyte acid concentrates. In fact, Fresenius continued to market these products and attempted to convert other clinics to use of their acid concentrates, even though they were aware that inadequate information was provided to these outside physicians.
The FDA reportedly received a copy of this internal memo from an anonymous source in March 2012, which prompted Fresenius to finally issue a broad warning to other clinics and the medical community.
Due to the risk of severe injury or death from continued use of the products with inadequate warnings, the FDA classified the action as a Granuflo recall and Naturalyte recall.
Fresenius Lawsuits Over Failure to Recall Granuflo and Naturalyte
As a result of Fresenius Medical Care’s failure to provide adequate warnings or issue a prompt recall of Granuflo and Naturalyte, thousands of people throughout the United States have likely suffered a heart attack, cardiac arrest or sudden death.
The NaturaLyte and GranuFlo recall lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for kidney dialysis patients who have suffered injuries as a result of Fresenius’ decision to place their desire for profits before consumer safety. Request a free consultation and claim evaluation.