GranuFlo Recall

About the GranuFlo Recall

In November, 2011, Fresenius released an internal memo to the doctors of their own clinics. This memo claimed that over 900 patients suffered heart attacks as a result of their dialysis process. This internal memo was leaked to the FDA by an anonymous source which resulted in an inquiry being sent to FMC regarding the side effects of GranuFlo and NaturaLyte in March 2012.  Two days later FMC released an ‘URGENT’ dialysis warning to non-FMC owned clinics.

Due to the findings of the inquiry the FDA issued a Class I Naturalyte and GranuFlo recall for products manufactured between January 2008 and June 2012.  Steven Silverman the Director of Compliance for the FDA’s Medical Device Division stated in an interview, “Personally, I’m troubled by the fact that Fresenius, on it’s own initiative didn’t notify it’s entire customer base of this particular concern.”

A Class I recall is an alert to the public to adverse health reaction and death resulting from use of the drug.  This required proper dosing information and labelling updates on newly manufactured GranuFlo and NaturaLyte products.  It also specifically warned the doctors and clinics on the dangers as a result of improper dosing.  The GranuFlo recall did not require these products to be removed from clinics.

When asked by the New York Times why the memo was not distributed to non-FMC clinics Dr. Franklin W. Maddux, Chief Medical Officer for FMC in North America was quoted as saying, “I felt that it was not in a condition for general consumption.”  His office was responsible for it’s own company centers and he had no way of communicating to non-company clinics except through papers in medical journals.  The findings of the internal memo were too preliminary to warrant a publication.

What caused the GranuFlo recall?

GranuFlo and Naturalyte contain an active ingredient called Sodium Diacetate, which has two parts: acetate and bicarbonate. Together, these ingredients work to neutralize acid in the bloodstream which the kidneys aren’t able to filter out. The problem arises because the acetate in GranuFlo and Naturalyte, which doesn’t exist in other products, is converted by the liver into bicarbonate. This raises the patient’s blood levels of bicarbonate even more than if the solution had just contained bicarbonate. Unfortunately, an excess of bicarbonate in the blood – a bicarbonate overdose – often results in heart attacks, low blood pressure, and other problems.

Fresenius knew that GranuFlo was presenting an enhanced risk of patients suffering a heart attack and other side effects, and even warned its own doctors about this. However, they failed to warn other clinics which used these products until an internal memo was leaked to the FDA, despite more than 100,000 dialysis patients being treated with GranuFlo and Naturalyte at these clinics.

Join the GranuFlo Lawsuit

Fresenius has agreed to a $250 million settlement to be paid to parties in the GranuFlo lawsuit. If you suffered any injuries as a result of your Naturalyte or GranuFlo dialysis treatment, you may be entitled to some of this money.

However, there is a deadline to become a party to the GranuFlo lawsuit, so you must act fast.

If you’d like to join the GranuFlo lawsuit, please don’t hesitate – contact us today, or call (877) 234-7573 to speak with one of our GranuFlo specialists.