FDA Issues Class 1 Recall of GranuFlo
In late March 2012, the FDA became aware of the apparent link between GranuFlo and cardiac arrest, according to the New York Times. In response to information about this threat to dialysis patients, which GranuFlo producer Fresenius had not made public, the FDA issued a Safety Communication warning about the dangers of alkali dosing errors for products like GranuFlo and NaturaLyte in hemodialysis patients.
In June, the FDA then issued a Class 1 recall of GranuFlo. This is the most serious class of recall, issued when the FDA deems there to be “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” The FDA described the reason for the recall thus:
The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
The New York Times now reports that an FDA investigation has begun to determine whether Fresenius violated federal regulations by failing to disclose risks associated with their product.
The New York Times has reported that an FDA investigation has begun to determine whether Fresenius violated federal regulations by failing to disclose risks associated with their product. Now, lawsuits alleging claims on behalf of individuals who were injured or lost a loved one after using GranuFlo have been filed by Gibbs Law Group in federal and California state courts.
FDA Recall Notice
Injured by GranuFlo during dialysis?
Our GranuFlo lawyers represent people nationwide who suffered cardiac arrest or lost a loved one following treatment with GranuFlo. If you believe GranuFlo caused or contributed to the development of heart problems in you or a loved one, including a sudden heart attack or cardiac arrest, hemodialysis cardiac arrest or cardiopulmonary arrest, stroke, or arrhythmia, you may want to speak to a GranuFlo lawyer.
Free and confidential consultations with our GranuFlo attorneys are available by filling out the form to your right or calling toll-free: (866) 981-4800.