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Recall affects dialysis treatments

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A pair of dialysis treatments - known as Granuflo and NaturaLyte - was the focus of a recent lawsuit and recall, after a number of patients died following alleged dosing errors at certain dialysis centers.

Both Granuflo and NaturaLyte are manufactured and distributed by Fresenius Medical Care, and were used to treat renal failure during hemodialysis from 2008 through mid-2012.

Both Granuflo and NaturaLyte contain acetic acid and sodium acetate, which work together to form bicarbonate and clean patients' bloodstreams.

However, an investigation by the FDA found that many doctors were using improper doses of the drug. That created dangerously high bicarbonate levels, leading to potential side effects such as cardiac arrest, strokes, low blood pressure and even death in some cases.

Fresenius Medical Care issued a Class 1 recall in 2012, after issuing a warning about the potential dosing errors. It is updating product labels for both Granuflo and NaturaLyte, as well as changing operating manuals for the dialysis machines which it is used with.

For many families, this issue has created a great deal of uncertainty. Because the drug is used to treat both acute and chronic kidney failure at major dialysis centers including Fresenius and DaVita, some patients who underwent emergency treatment may not be fully aware of the treatments that were used, and if the recall may affect them. 



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