Class I Recall of Naturalyte and Granuflo

Class I recalls involve products or situations that can result in serious health risks and death.

Fresenius Medical Care North America has recalled Naturalyte and Granuflo Acid Concentrate. They are used in the treatment of acute and chronic renal failure during hemodialysis. This concentrate is intended to be used with a three-stream hemodialysis machine.

The manufacturer is warning clinicians to be aware of the concentration of acetate or sodium diacetate that are contained in these products. If prescribed incorrectly, it can lead to a high serum bicarbonate level in patients who are undergoing this treatment. It could possibly contribute to metabolic alkalosis. The warning also states that this product could cause very serious health consequences, even resulting in death.

The FDA determined that Fresenius failed to inform doctors of the potential risks of using these products. This put thousands of dialysis patients at risk.

The FDA comments that Class I recalls are the most serious type of recalls. They involve products or situations that can result in serious health risks and death.

If you or a love one has been the victim of Naturalyte or Granuflo use, contact the St. Louis dialysis injury lawyers at the Zevan and Davidson Law Firm today. We have represented a wide variety of medical negligence victims in St. Louis, Missouri and Illinois.

Call Now (314) 588-7200 or schedule your free consultation.

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