GranuFlo RecallLawsuits Being Filed After Dialysis Concentrate Recall
Class I Recall on GranuFlo
The US Food and Drug Administration (FDA) issued a Class I recall on GranuFlo Dry Acid Concentrate and Naturalyte Liquid, dialysis products used in the treatment of acute and chronic renal (kidney) failure during hemodialysis. Class I recalls are the most serious type of recall issued by the FDA for products that may cause serious health issues or death.
The FDA recall on GranuFlo warns that these products can lead to low blood pressure, heart attack and even death.
What is GranuFlo?
GranuFlo is prescribed for use in the treatment of acute and chronic renal failure during dialysis. This product is used with the hemodialysis machine and dialyzer for the purpose of removing waste from the blood. GranuFlo is manufactured by German manufacturer, Fresenius (FMC). Over 100,000 dialysis patients have used GranuFlo at around 5700 clinics in the United States at an estimated revenue of at least $80 million.
GranuFlo contains a powdered form of acetic acid which the dialysis clinics then mix to form the dialysate solution used for treatment. The FDA received a complaint that the directions for mixing and using GranuFlo were incomplete and put the patients at risk of bicarbonate overdosing.
Fresenius Neglected to Warn Others of the Potential Deadly Problem
An internal memo issued by Fresenius on November 4, 2011 disclosed that the manufacturer was aware of the dangers of GranuFlo. The memo confimed that there was a significant risk of cardioplumonary arrest and death for patients undergoing dialysis treatment at the clinic due to the incorrect dialysate concentration. This information was only shared with physicians and clinics associated with Fresenius. According to their report, 941 patients treated at FMC clinics had cardiac arrests during or shortly after treatment.
FMC neglected to provide knowledge of this high risk associated with the use of GranuFlo to non FMC clinics and medical professionals. It was not until five months later, in March 2012 that the memo was leaked to the FDA which then sent an inquiry about GranuFlo. The FDA issued the Class 1 recall on June 27, 2012 as a result of that inquiry.
Risks Associated With the Use of GranuFlo
According to the FDA recall, GranuFlo’s concentration of acetate or sodium diacetate can lead to a too high serum bicarbinate level while undergoing dialysis. This can lead to the following:
- low blood pressure
- hypokalemia (low potassium)
- hypoxemia (low blood oxygen)
- cardiac arrhythmia
- cardiac arrest
Many patients suffered adverse health effects due to the inappropriate dosing errors of GranuFlo while still at the dialysis clinic or shortly after treatment.
What Should You do if You or a Loved One Uses GranuFlo
If you or a loved one use GranuFlo for dialysis treatments, discuss the danger of bicarbonate overdosing with your medical professional. This risk has been associated with sudden heart attacks and even death in hemodialysis patients. Be sure you understand how your hemodialysis device mixes GranuFlo and have your doctor review the labeling for the specific concentration they have prescribed.
You may have a claim against the manufacturer of GranuFlo, Fresenius Medical Care. Contact the GranuFlo Lawsuit lawyer at D. Miller & Associates, PLLC if you or a loved one, have used GranuFlo and suffered from a heart attack or death during or after dialysis treatment.
Remember, this manufacturer was aware of the risk of serious heart issues and death but chose not to share this information with the public or the FDA until the memo was leaked. As a result, your lawyer will fight to get you compensation for your additional medical costs, rehabilitation, loss of income and any other claims that may apply to your case. Call us now at 1-855-776-5299 or use the convenient form on this page for your free consultation.