D. Miller & Associates, PLLC Announcing Class 1 FDA Recall on GranuFlo
The US Food and Drug Administration (FDA) issued a Class 1 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 1 FDA Recall on GranuFlo
The US Food and Drug Administration (FDA) issued a Class 1 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 1 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).
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•death
Many patients suffered adverse health effects due to the inappropriate dosing errors of GranuFlo while still at the dialysis clinic or shortly after treatment
.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 be able to claim compensation from Fresenius Medical Care if you or a loved one, have used GranuFlo and suffered from a heart attack or death during or after dialysis treatment.
D Miller & Associates PLLC provides quality and aggressive legal representation. To find out more about your rights, visit http://dmillerlaw.com today. Call us toll free at 1-855-776-5299
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- Melo Pisha
- D. Miller & Associates, PLLC
- (1) (713) 779-3476
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