GranuFlo & NaturaLyte Recall

The attorneys at Sanders Phillips Grossman are ready to help with injuries sustained by a defective product.

Sanders Phillips Grossman, LLC is a joint venture firm of Phillips Law Firm and Sanders Viener Grossman merging the best of the West Coast and East Coast’s top Mass Tort Firms to join forces against America’s greediest drug and medical device companies.

Victims are seeking compensation for their injuries from Fresenius Medical Care (FMC), the maker of these defective drugs. Linked to hundreds of deaths, these pharmaceutical products thought to be dangerous and yet FMC failed to take action in removing the products from the market. Recently GranuFlo and NaturaLyte were finally recalled after a definitive announcement from the U.S. Food and Drug Administration.

If you or a loved one has suffered heart complications, including heart attack, or cardiac event, after dialysis with GranuFlo or NaturaLyte, please contact the attorneys. You may be entitled to compensation for the damages caused by these dangerous products. We are waiting 24/7 to answer your questions any time of day or night with a free case consultation. Remember that we have a no fee promise, meaning if we do not recover compensation for you, you do not owe us an attorney fee.

What is Naturalyte and Granuflo Concentrate?

The Naturalyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates. (FDA)

What is the potential risk factor with this product?

The U.S. Food and Drug Administration (FDA) has announced a Class I recall (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) on the dialysis product GranuFlo and NaturaLyte due to serious side effects.

Fresenius on March 29, 2012 Urgent Product Notification to their clinics and customers of the potential increased risk of bicarbonate overdose as a result of human error when dialysates are mixed incorrectly. The dialysis solution is comprised of two acid concentrates which are diluted and used in hemodialysis treatment of acute and chronic renal (kidney) failure patients. Unlike other acid concentrate products which primarily consist of acetic acid, GranuFlow and NatraLyte contain acetic acid and sodium acetate (or sodium diacetate) which as then diluted with purified water and bicarbonate. When sodium acetate is converted into bicarbonate by the patient’s liver the overall concentration of bicarbonate levels are beyond a safe level and lead to high serum bicarbonate levels in patients.

Incorrectly mixed dialysate result in increased bicarbonate levels which can place patients at an increased risk of 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.” (FDA)

Potential Overdose Side Effects

  • Low blood pressure (hypotension)
  • Heart attack or myocardial infarction
  • Heart Problems
  • Cardiopulmonary arrest
  • Metabolic alkalosis
  • Stroke
  • Death

Serial numbers for 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, 13-4325-1

Serial numbers for 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

ABOUT SANDERS PHILLIPS GROSSMAN

Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers, or surgical instruments can harm patients when the product is defective in the manufacturing process, design, or marketing strategy.

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