FDA Recalls Granuflo and Naturalyte Due to Heart Risks for Dialysis Patients
Patients on dialysis for the treatment of chronic kidney failure may be at a higher risk for cardiac arrest. The FDA recently issued a Class I recall on Granuflo and Naturalyte, two dialysis products manufactured by Fresenius Medical Care that are used in over 1,800 of its treatment facilities across the U.S. and sold to hospitals and clinics. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The FDA noted that physicians and health care providers should be cautious of the concentration of these products to protect patients against an overdose. Granuflo and Naturalyte have been linked to elevated bicarbonate levels in the blood which can lead to cardiac arrest and death. Other serious side effects include:
• Irregular heartbeat
• Low blood pressure
• High carbon dioxide levels in the blood
• Low blood oxygen pressure
If you or someone you care about has used Granuflo or Naturalyte in dialysis treatment of chronic kidney failure and has suffered a serious injury, contact us. Our product liability personal injury attorneys have experience with lawsuits involving dangerous drugs and medical devices and can advise you about your legal rights and options.