In March 2012, the U.S. Food and Drug Administration (FDA) announced a Class I recall of NaturaLyte and GranuFlo Acid Concentrates, which are used in the treatment of acute and chronic renal failure during hemodialysis.
The FDA said the recall was prompted by the risk that improper doses of these products could lead to elevated bicarbonate levels in patients. This could lead to metabolic alkalosis, which is a significant risk factor associated with heart attacks and other serious health problems, according to the FDA.
These additional health problems include:
- Low potassium levels
- Low oxygen levels
- Elevated carbon dioxide levels
- Irregular heart beat.
A Class I recall is the most serious type of recall. It is reserved for situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
GranuFlo and NaturaLyte are made by Fresenius Medical Care North America of Waltham, Massachusetts. They were manufactured and distributed from January 2008 through June 2012, the FDA says.
NaturaLyte / GranuFlo Manufacturer Had Data Indicating Problems
At the same time as its Class I recall of NaturaLyte and GranuFlo, the FDA issued a notice to health care professionals about the use of all hemodialysis dialysate concentrates containing acetate, acetic acid or citrate.
The warning was addressed to health care professionals using dialysis equipment and prescribing dialysate concentrates, including:
- Dialysis technicians
- Hospital and clinic administrators
- Medical officers
- Risk managers
- Dialysis clinics.
The warning cites a report from the National Kidney Foundation 2011 Spring Clinical Meetings that evaluated 50 hemodialysis patients who were hospitalized in October 2010. The report said 54 percent had a serum bicarbonate level that was above the level triggering metabolic alkalosis.
Also, at the same time as the FDA’s recall, Fresenius issued a “Firm Urgent Product Notification.” The notification said, in part, that the company’s own patient safety data confirmed the exact same risk of metabolic alkalosis that had led to the FDA recall notice.
Contact a GranuFlo / NaturaLyte Injury Lawyer Today
The March 2012 recall of GranuFlo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate is of no help to kidney dialysis patients who had already suffered heart attack, convulsions, heart failure, heart arrhythmia, death or other complications of metabolic alkalosis after NaturaLyte or GranuFlo was used in their treatment.
If you or a loved one received GranuFlo or NaturaLyte during dialysis and suffered an adverse reaction, you should act to protect your rights now. An experienced GranuFlo / NaturaLyte injury lawyer can explain your legal options to you today.
Contact The Driscoll Firm, LLC, by calling our toll-free number or using our online contact form. You may be able to obtain compensation to help defray the costs of medical expenses, lost income and other losses and for your pain and suffering.
The personal injury and wrongful death lawyers of The Driscoll Firm, LLC, have a successful record of helping clients who have been injured by faulty pharmaceuticals and medical devices. John J. Driscoll, the firm’s founding attorney, is a member of the Million Dollar Advocates Forum and the Multi-Million Dollar Advocates Forum. We’re ready to get started on your case today.
For more information:
- Medical Device Recalls – Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, U.S. Food and Drug Administration
- FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis, U.S. Food and Drug Administration
- NaturaLyte Liquid and Granuflo Acid Concentrate Bicarbonate Alkalosis, Fresenius Medical Care North America