Granuflo and NaturaLyte are dialysis products manufactured by Fresenius Medical Care. Each of these devices contains acetate or sodium diacetate and is frequently used during the hemodialysis treatment phase of patients who suffer from renal (kidney) failure. Previously, it was a common belief that these dialysis products were safe for consumer use, however, on September 5, 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall. Generally, the FDA will issue a Class I warning when a company’s product or device has a reasonable probability that due to an exposure or use, it can create an adverse health consequence or death.
In November 2011, Fresenius Medical Care issued an internal memo which revealed that approximately 941 patients who had been administered Granuflo and NaturaLyte in 2010, died as a result. But, the company failed to notify the public, doctors, patients or potential consumers of this serious health risk. After receiving an anonymous report of these severe adverse consequences, the FDA conducted an investigation and issued its recall in September 2012.
It has been discovered that Granflu and NatuaLyte contain higher levels of bicarbonate than other dialysis products. As a result of these increased levels, patients are more likely to suffer from bicarbonate overdose which can lead to serious medical complications, among which include cardiac arrests (heart attacks) or death. If you or a loved one is among the estimated 40,000 kidney failure patients who undergo treatment with the Granuflo or NaturaLyte dialysis tools, studies suggest that you are six times more likely to suffer from a cardiopulmonary arrest or sudden heart attack.
In addition to the risk of heart attack, several other side effects have been linked to the Fresenius Medical Care’s dialysis products including:
Lawsuits are being filed against Fresenius Medical Care by victims who suffered an injury or had a loved one who died after use from the company’s product. A Fresenius Lawsuit attorney can be found in the Law Info’s directory if you or your loved one has suffered any adverse side effect including a heart attack, stroke, cardiopulmonary arrest or death. You may be entitled to receive compensation from the company, Fresenius Medical Care since they have failed to warn its consumers or doctors about these serious health consequences, and for negligently manufacturing and distributing a dangerous product when they were aware of its propensity to harm its users.
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