Dialysis medication recall

GranuFlo Recall, Dialysis Medication Lawsuits, Heart Attack From Dialysis Medication Lawyers

GranuFlo is used in Dialysis treatment. it has been recalled due to sudden heart attacks and deaths. Heart attack from dialysis medication lawyers are filing lawsuits for deaths from dialysis medications.

Definitions and Kindney Disease Overview

Chronic kidney disease (CKD): any condition that causes reduced kidney function over a period of time. CKD is present when a patient’s glomerular filtration rate remains below 60 milliliters per minute for more than 3 months or when a patient’s urine albumin-to-creatinine ratio is over 30 milligrams (mg) of albumin for each gram (g) of creatinine (30 mg/g).

End-stage renal disease (ESRD): total and permanent kidney failure. When the kidneys fail, the body retains fl uid. Harmful wastes build up. A person with ESRD needs treatment to replace the work of the failed kidneys.

Acute kidney injury (AKI): sudden, temporary, and sometimes fatal loss of kidney function

incidence: the number of new cases of a disease in a given time period

prevalence: the number of existing cases of a disease at a given point in time


Chronic Kidney Disease, Dialysis and GranuFlo. GranuFlo is a Threat to Seniors

  •     The incidence of CKD is increasing most rapidly in people ages 65 and older.
  •     The incidence of recognized CKD in people ages 65 and older more than doubled between 2000 and 2008.
  •     The incidence of recognized CKD among 20- to 64-year-olds is less than 0.5 percent.

CKD Prevalence, GranuFlo Threat in 60 and Over Population

    The prevalence of CKD is growing most rapidly in people ages 60 and older.
    Between the 1988–1994 National Health and Nutrition Examination Survey (NHANES) study and the 2003–2006 NHANES study, the prevalence of CKD in people ages 60 and older jumped from 18.8 to 24.5 percent.
    During that same period, the prevalence of CKD in people between the ages of 20 and 39 stayed consistently below 0.5 percent.

Dialysis Statistics By State

  • Alabama: 7,334
  • Alaska: 350
  • Arizona: 6,747
  • Arkansas:2,905
  • California: 45,047
  • Colorado: 3,360
  • Connecticut: 3,497
  • DC:1,809
  • Delaware: 1,170
  • Florida: 20,365
  • Georgia: 14,086
  • Hawaii: 2,449
  • Idaho: 916
  • Illinois: 15,268
  • Indiana: 6,539
  • Iowa: 2,296
  • Kansas: 2,384
  • Kentucky: 4,262
  • Louisiana: 7,287
  • Maine: 975
  • Maryland: 7,823
  • Massachusetts: 5,123
  • Michigan:12,293
  • Minnesota: 3,697
  • Mississippi:5,456
  • Missouri:6,467
  • Montana: 627
  • Nebraska:1,473
  • Nevada: 2,294
  • New Hampshire: 690
  • New Jersey: 10,580
  • New Mexico: 2,451
  • New York: 23,612
  • North Carolina: 12,895
  • North Dakota: 501
  • Ohio: 13,761
  • Oklahoma:3,793
  • Oregon: 2,703
  • Pennsylvania: 14,201
  • Puerto Rico:4,032
  • Rhode Island: 838
  • South Carolina: 7,199
  • South Dakota: 689
  • Tennessee: 7,482
  • Texas: 32,383
  • Utah: 1,303
  • Vermont: 380
  • Virginia: 9,332
  • Washington: 5,026
  • West Virginia: 1,794
  • Wisconsin: 4,899
  • Wyoming:248


The high incidence of Dialysis treatment in Florida is due to the numbers of aging population. Our Florida Seniors are at risk for sudden heart attack form the dialysis medication GranuFlo and Naturalyte.

Fresenius labs has used GranuFlo and Naturalyte in Dialysis  Treatments. Fresnius knew of the dangers and still used the medication. As a result many of our seniors have suffered cardiac arrest and heart problems

Fresenius  Claima  To Be Patient-Centered Care for Chronic Kidney Disease

Fresenius Medical Care North America is a major provider of kidney dialysis services and renal care products. We provide products, dialysis care services, education and support for Chronic Kidney Disease (CKD), including treatment options for later stage CKD.

Our dialysis care services include hemodialysis, peritoneal dialysis, education tools and transplant support services, in-center, at home, or in a hospital, to fit our patients' needs. We manufacture and distribute a variety of dialysis products and equipment, including dialysis machines, dialyzers and other dialysis-related supplies.

FDA Issues Class 1 Recall of GranuFlo

In late March of 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.

GranuFlo Lawsuits Mounting Up. Protect Our Seniors, File Your GranuFlo Lawsuit Today

GranuFlo and NaturaLyte lawsuits are being filed in courts around the country, after hundreds of patients suffered cardiac arrest, sudden cardiac death. Pur seniors are in danger.  Serious heart problems have been reported following  the use of the drugs during dialysis treatments.   While Fresenius Medical, the manufacturer of GranuFlo and NaturaLyte, learned of the risks associated with the dialysis drugs in 2011, a GranuFlo and NaturaLyte recall was not announced until months later. GranuFlo and NaturaLyte lawsuits are now being filed on behalf of our seniors  who are victims of  serious heart side effects within 48 hours of a dialysis treatment with  GranuFlo and Naturalyte. Problems include: sudden cardiac death, cardiopulmonary arrest, heart attack and the development of heart problems.
 

File Your GranuFlo Lawsuit and Protect Your Loved Ones. Get Justice form Manufacturers who value profits over harm to people. If you, a loved one or someone you are a caregiver for has been injured by a dialysis medication call the GranuFlo Lawyer Helpline of Free Legal Shiels today.


 

GranuFlo Lawyers, NaturaLyte Lawsuits

 

Fresenius Medical is the manufacturer of  GranuFlo and NaturaLyte acid concentrate. These are drugs used in  dialysis treatment. There has been a recall of these dialysis drugs and  lawsuits are being filed.

Injury and death has resulted from these drugs:

  •  GranuFlo cardiovascular death,
  •  GranuFlo sudden cardiac death,
  •  GranuFlo cardiopulmonary arrest,
  •  GranuFlo heart attack,
  •  GranuFlo catastrophic cardiovascular injuries

 

Fresenius manufactures GranuFlo and NaturaLyte used in dialysis. These drugs cause alkalosis, a condition associated with an increase in cardiovascular fatalities.

 

The FDA received complaints describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis.

 

This can contribute to metabolic alkalosis, which is a significant risk factor associated with :

 

Low blood pressure

Cardiopulmonary arrest

Cardiac arrhythmia

Sudden heart attack

Stroke

Hemodialysis cardiopulmonary arrest

 

A study which was conducted between January and December of 2010 found that patients with pre-dialysis bicarbonate levels greater than 28mEq/L were 4.7 times more likely to suffer a cardiac arrest. The study also discovered that patients with pre-dialysis potassium lower than 4 mEq/L had a 6.3 times higher risk of cardiac arrest.

 

In May 2012 the FDA notified health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients’ dialysate prescription.

There is a GranuFlo and NaturaLyte Class 1 Recall

 

Serial numbers for recalled Naturalyte Liquid Acid Concentrate range from:

 

08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-

 

Serial numbers for recalled Naturalyte GranuFlo (powder) Acid Concentrate range from:

 

OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B

GranuFlo & NaturaLyte is one of the most widely prescribed dry acid products used for dialysis  at Fresenius'  clinics, as well as other hemodialysis centers that purchase their dialysis supplies from Fresenius.  It is estimated that 125,000 patients in non-Fresenius clinics are treated with GranuFlo.

Dilaysis Patient Alert

If you, a loved one or someone you care for has been injured by these products contact us for a GranuFlo and NaturaLyte lawsuit.