NEW YORK—GranuFlo and NaturaLyte, both Fresenius Medical dialysis concentrates,  have been classified by the U.S. Food and Drug Administration (FDA) as Class I recall products, placing them in the agency's most serious medical device recall category.

In March 2012, Fresenius issued an Urgent Product Notification warning its customers that GranuFlo and NaturaLyte are associated with elevated bicarbonate levels, a significant risk factor for cardiac arrest. Parker Waichman LLP first reported on these issues in a press release issued by the firm on June 21, 2012.

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

GranuFlo and NaturaLyte are alkaline substance administered to dialysis patients to neutralize the acid that builds up in the blood. The products are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body.

According to the Times, Fresenius is being investigated for failing to warn its customers about the serious risks associated with GranuFlo and NaturaLyte. According to the report, Fresenius had issued an internal memo to its own clinics on November 4, 2011, warning that 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. The company conducted an analysis of these patients, comparing them to over 80,000 other dialysis patients in the same centers. Overall, the data indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients.

While Fresenius alerted its own physicians and medical directors about the issue, it did not notify the public or the FDA about the findings until the agency received an anonymous copy of the memo and inquired about it. In May, the FDA issued a Safety Communication warning about alkali dosing errors for products like GranuFlo and NaturaLyte in hemodialysis patients. “Given that Fresenius’ actions or inaction raise concerns as to whether Fresenius is capable of appropriately advising facilities using GranuFlo and NaturaLyte Dialysis Products of their inherent danger, FDA’s Class I recall is a welcomed action,” says Matthew McCauley, senior litigation counsel at Parker Waichman LLP. “By taking this action, FDA essentially ordered Fresenius to take the necessary steps to advise ALL, not just Fresenius owned, facilities using GranuFlo and NaturaLyte Dialysis Products that these products are being investigated for serious safety concerns.”

As stated on the FDA website, health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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