On June 28, 2012, Fresenius Medical Care North America (FMCNA) announced that the US Food and Drug Administration (FDA) issued a Class 1 recall on the GranuFlo® Dry Acid Concentrate and NaturaLyte® Liquid, dialysis products used in the treatment of acute and chronic renal (kidney) failure.
Did you know that this using this dangerous medical product can cause recipients to suffer from cardiac arrest, cardiac pulmonary arrest, or death?1 Those victims and their families may be eligible to pursue damages through legal action.
Whether you or a loved one suffered due to GranuFlo® or NaturaLyte®, Peterson & Associates, P.C. is ready to stand on your behalf. Complete a case evaluation today.
What Are GranuFlo® & NaturaLyte®?
Kidney failure affects around 2 out of every 1,000 individuals in the U.S. In order to keep blood filtered correctly, an individual would need to go through hemodialysis, which is a process that removes toxins and waste from the blood. GranuFlo® (powder) and NaturaLyte® (liquid concentrate) are used in the treatment of acute and chronic renal failure during hemodialysis.
The recalled NaturaLyte® and GranuFlo® (powder) products were manufactured by Fresenius Medical Care North America (FMCNA) and distributed from January 2008 through June 2012. Fresenius Medical Care is one of the largest dialysis clinic operators in the world.
Some issues people were experiencing included:
- Irregular heart beats
- Low blood pressure
- Risk of stroke
- High level of carbon dioxide in blood
- Low blood oxygen
- Low levels of potassium
- Muscle damage
- Cardiac pulmonary arrest
GranuFlo® & NaturaLyte® Recalls
A Class 1 recall is the most serious type of recall issued by the FDA. This step is taken for products that may cause serious health issues or even death. The FDA issued a Class 1 recall for both GranuFlo® and NaturaLyte®, indicating the severe risk users had undergone.
As GranuFlo® and NaturaLyte® can be used for the treatment of acute or chronic kidney failure, it is possible that patients undergoing emergency dialysis treatment may not know what dialysis drug they were given. As a result, an individual could have exposed themselves to a heightened risk of cardiac arrest and death by taking GranuFlo® or NaturaLyte® without realizing it.
Our Kansas City drug injury lawyers care about securing justice for injury victims.
Start by calling our firm today at 816-888-8888.
Peterson & Associates, P.C. Can Investigate Your Case
Some have claimed in the past that Fresenius misled consumers regarding the drugs’ safety and withheld information about the risk of heart attacks from various doctors and healthcare workers. If you or a loved one suffered similar conditions or symptoms to the ones listed above following the use of GranuFlo® or NaturaLyte® for dialysis treatment, Peterson & Associates, P.C. can help.