On March 29, 2012, the Federal Drug Administration (FDA) recalled GranuFlo, a powder acid concentrate, and Naturalyte, a liquid acid concentrate. Both products had been linked to cardiopulmonary arrests in dialysis patients.
GranuFlo and Naturalyte were manufactured and distributed between January 2008 through June 2012 to Fresenius Medical Care North America and other dialysis centers. After three years of its distribution, Fresenius informed its medical directors and physicians of the health causes associated with GranuFlo. These concentrates were mixed with hemodialysis machines to neutralize acid in the blood for patients suffering from acute and chronic renal failure.
The concentrates cause heightened levels of bicarbonate in the patient’s blood, putting the patient at a risk six times higher for having cardiopulmonary arrests and strokes. Fresenius reported the findings to other dialysis centers a year later.
If you or a loved one is considering a GranuFlo or Naturalyte recall case, Brayton Purcell encourages you to make a consultation to find out what your legal rights are.