More than 300 lawsuits have been filed against Fresenius Medical Care arising from problems with GranuFlo and NaturaLyte dialysis products. Both GranuFlo and NaturaLyte were subject to a Class I Recall after serious risks arose and the Food and Drug Administration (FDA) became concerned about the link between GranuFlo/NaturaLyte and patients suffering cardiac arrest.
Our Boston dialysis drug lawyers know that the Class I Recall occurred in March of 2012 and included a voluntary change of the labels on both the NaturaLyte and GranuFlo products. This recall occurred months after an internal memo was sent out by Fresenius Medical Care on November 4, 2011, alerting physicians at Fresenius’ own dialysis clinics that GranuFlo and NaturaLyte could result in excess bicarbonate in the body if doctors did not specifically adjust for the fact that GranuFlo and NaturaLyte reacted differently than other alkaline substances used in dialysis treatment.
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