The United States Food and Drug Administration (FDA) recently declared that Fresenius Medical Care’s recent warning to the public about its products GranuFlo and Naturalyte for dialysis will lead to a Class I recall. A Class I recall by the FDA is the most serious category of recalls for a medical device.
In March of 2012, Fresenius released an Urgent Product Notification to warn consumers that it’s dialysis products GranuFlo and NaturaLyte have been linked with higher bicarbonate levels among patients which is a serious problem related to causing cardiac arrest.
According to the Food and Drug Administration (FDA), a Class I recall is its most urgent form of recall which is typically only used when they have reason to believe that the continued use of a product may cause significant health consequences and even death. GranuFlo and Naturalyte are alkaline based substances which are given to patients undergoing dialysis in order to reduce the acid which builds up in the patient’s blood.
GranuFlo and Naturalyte are used combined with bicarbonate, and they contain acetate which is an ingredient that the body transforms into bicarbonate. The issue is that Fresenius Medical Care’s products, GranuFlo and Naturalyte have far more acetate than their rival products which results in patients having higher levels of bicarbonate.
According to various sources, the makers of GranuFlo and Naturalyte, Fresenius Medical Care is being investigated for not warning its customers about the significant risks linked to its products. According to one report, Fresenius had delivered an internal memo to its clinics in November of 2011 warning that almost 1000 hemodialysis patients had experienced cardiac arrest during 2010. They then compared these results with those of more than 80,000 other patients undergoing dialysis. Their findings were that the excess bicarbonate lead to a significant risk of heart trauma among hemodialysis patients.
Although Fresenius did warn its own physicians and medical directors about the dangers of GranuFlo and Naturalyte, it failed to warn the Food and Drug Administration (FDA) or the general public. The only reason the FDA discovered this hazard was that it received an anonymous copy of the internal memo passed around Fresenius and decided to investigate.
Fresenius is currently under investigation by the FDA to see whether the company violated federal regulations by not alerting all customers of GranuFlo & NaturaLyte of the health risks. The FDA issued a Class 1 recall of GranuFlo & NaturaLyte from all clinics on June 27, 2012.
If you or a loved one has experienced cardiac arrest, heart attack, stroke following dialysis with GranuFlo or Naturalyte, please contact the Willis Law Firm for a free consultation for a potential GranuFlo and Naturalyte dialysis lawsuit. You may be entitled to financial compensation from the makers of GranuFlo and Naturalyte in a GranuFlo and Naturalyte dialysis lawsuit.