Granuflo recall is a recall for those that may have been harmed by GranuFlo® and NaturaLyte® (sodium diacetate) are dialysates manufactured by Fresenius Medical Care, the largest operator of dialysis centers in the country. Dialysates work by filtering waste products from the blood for patients whose kidneys are no longer functioning properly. Dialysis is supposed to be a lifesaving and life-sustaining technology for individuals with renal failure. It should not put patients at risk of heart attack or death. Unfortunately, products by Fresenius Medical Care, known as Naturalyte and GranuFlo, contain ingredients that can cause heart attack risk to spike. Fresenius kept selling them without proper warnings after they knew about the risk.
On March 29, 2012, Fresenius sent an Urgent Product Notification to facilities using their dialysate products. This notification provided clinicians with important prescribing information regarding the use of GranuFlo and NaturaLyte.
What you need to know about the GranuFlo and Naturalyte Recall
Fresenius warned clinicians to be aware of the concentration of acetate contained in Fresenius’ GranuFlo and NaturaLyte products. Once administered, the acetate in GranuFlo and NaturaLyte is rapidly converted to bicarbonate by the liver. Inappropriate use of these products can cause an extreme drop in blood pressure, which can then lead to stroke or cardiac arrest.
Two months later, on May 25, 2012, the U.S. Food & Drug Administration (FDA) issued a Safety Communication, notifying health care providers that they had received complaints of dosing errors that occurred during hemodialysis, and to warn health care professionals to take special care when administering dialysates, like GranuFlo and NaturaLyte to patients.
In June 2012, the FDA issued a Class I recall for Fresenius’ GranuFlo and NaturaLyte products. The recall stated that Fresenius’ labeling was false and misleading, and required Fresenius to provide proper instructions for the use of GranuFlo and NaturaLyte. Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
How to get help with the Granuflo Recall
If someone you know may have been harmed by GranuFlo or Naturalyte, you are not alone. The team at CaseAdvisor believe in supporting individuals and families harmed by Fresenius. You could be eligible for a financial recovery that can help pay for medical bills, lost wages, pain, suffering, and the long term effects of living with a serious medical condition. Send us your contact information using the form on this page, and we will help you understand your rights and if you are entitled to compensation. This is a totally free service, with no hidden costs.
You May Be Entitled To Compensation. To receive a quick evaluation of your case at no cost to you, please contact us using the web form on this page. Consultation is free, and totally discreet.