The nation's largest dialysis operator — Fresenius Medical Care — is being investigated for failing to warn patients of a potentially deadly heart risk connected to excessive doses of its GranuFlo® and NaturaLyte® dialysis products.
Estimates show that 941 patients suffered cardiac arrest at Fresenius dialysis centers in 2010 alone.
On November 4, 2011, Fresenius sent a memo to doctors in its own network of dialysis centers warning of a serious risk found in using GranuFlo and NaturaLyte. According to the memo, GranuFlo and NaturaLyte have the potential to raise bicarbonate levels in patients’ blood more than other dialysis concentrates.
In June of this year, the FDA issued a Class 1 GranuFlo and NaturaLyte recall. Class 1 is used for products that the FDA has found to be extremely dangerous.
Fresenius Medical Care has issued important product notification and prescribing information regarding its NaturaLyte and Granuflo acid concentrates.
If you or someone you know has suffered a heart attack related to dialysis, contact the attorneys at Sheller, P.C. at 1-800-883-2299 or email@example.com to discuss your legal rights.