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Michele Van Almelo
Michele Van Almelo
Contributor • (800) 622-7271

FDA Class I Recall for Kidney Dialysis Products Granuflo and NaturaLyte

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Chronic kidney failure is a condition that affects about 2 million individuals worldwide. On June 27th, the Food and Drug Administration (FDA) issued a Class I Recall notice, the most serious product recall for compounds that can cause major health problems or death, for the products GranuFlo and NaturaLyte manufactured by Fresenius Medical Care North America. These are alkaline substances designed to be used as a key component for balancing acids in the human body during the dialysis process. However, GranuFlo and NaturaLyte contain higher levels of acetate than other products on the market, which can result in too many bicarbonates in the blood. The PH balance in the blood is then thrown off causing Alkolosis, a condition associated with an increase in cardiovascular death and catastrophic cardiovascular injuries.

Fresenius Medical Care (FMC) is being investigated for failing to warn its customers about the serious risks associated with GranuFlo and NaturaLyte. An internal memo dated November 4, 2011 indicates that FMC had knowledge that there were serious risks including death that were associated with their concentrates that contain sodium diacetate. Top FMC officials knew about the potential problems since the product's launch in 2003. Around 2010, they were fully aware of the hazards and clinical problems that existed. While FMC alerted their own physicians and clinics that were using GranuFlo and NaturaLyte, they did not report the problem to the FDA, and they withheld the information from outside sources using the product line.

If you or someone you know has suffered one of the following: cardiovascular death, sudden cardiac death, cardiopulmonary arrest, heart attack, or any other catastrophic cardiovascular injuries within 48 hours of using these products with dialysis please contact a lawyer for your claim. Reich and Binstock is currently taking cases of this nature, you can contact us at (800) 622-7271, or www.reichandbinstock.com if you think you may have been affected by this recall.