GranuFlo Dialysis Products Recall Lawyers

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of Granuflo Dry Acid Concentrate and NaturaLyte Liquid Acid Concentrate.

Class I recalls are the most serious type of recall, and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death, according to the FDA.

The FDA said in March 2012 that improper doses of GranuFlo and Naturalyte can contribute to elevated bicarbonate levels in hemodialysis patients, which can cause metabolic alkalosis, a pH imbalance in which the body has accumulated too much of an alkaline substance.

Metabolic alkalosis is a significant risk factor associated with:

  • Cardiopulmonary arrest (heart attack)
  • Cardiac arrhythmia (irregular heart rate)
  • Hypoxemia (low blood oxygen)
  • Hypercapnia (increased carbon dioxide in the blood)
  • Hypokalemia (low potassium levels in the blood)
  • Low blood pressure

GranuFlo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate were manufactured and distributed by Fresenius Medical Care North America of Waltham, Massachusetts, from January 2008 through June 2012.

Serial numbers for GranuFlo Acid Concentrate affected by the recall are:

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

Serial numbers for Naturalyte Liquid Acid Concentrate affected by the recall are:

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

How the GranuFlo / Naturalyte Acid Concentrate Recall Affects You

The FDA recall of GranuFlo Acid Concentrate powdered hemodialysis supplement and Naturalyte Liquid Acid Concentrate includes a statement of caution to clinicians who use the product in dialysis setups. The accompanying Urgent Product Notification, which Fresenius Medical Care North America sent to their clinics and customers, instructs clinicians to “exercise their best clinical judgment regarding the bicarbonate and total buffer base prescription for each patient.”

The FDA says consumers as well as health care professionals may report adverse reactions or quality problems they experienced using GranuFlo Acid Concentrate or Naturalyte Liquid Acid Concentrate to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

MedWatch reports may be made online or on a paper form that can be downloaded here and FAXed to 1-800-FDA-0178 or mailed to an address printed on the form. 

Contact Our GranuFlo Dialysis Products Recall Lawyers Today

The nationally recognized medical product liability team of Cohen and Malad, LLP, are investigating GranuFlo and Naturalyte personal injury and wrongful death claims in the wake of the recent recall of these dialysis treatment products.

If you or a loved one has suffered adverse side-effects following use of GranuFlo or Naturalyte acid concentrates, we can help you.

Protect your rights! Don’t delay!

Contact the GranuFlo dialysis products recall attorneys of Cohen and Malad, LLP, today by calling us toll free or through our online form. We offer a free, no obligation consultation.

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