NxStage Medical Inc. has recalled SAK Concentrate, a dialysis product, because it may contain high levels of aluminum. Although NxStage says levels are not high enough to cause patient harm, some users have reported side effects. In addition, it took the company nearly a year to discover the problem and recall the products.
What You Can Do & How a NxStage Dialysis Recall Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting NxStage dialysate induced injury cases in all 50 states. If you or somebody you know was injured by aluminum poisoning, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Overview
NxStage SAK Concentrate is a dialysis concentrate that contains electrolytes, buffer, and glucose. It is supposed to be mixed with water to form a liquid dialysis fluid that flushes wastes out of a patient’s blood. It is meant to be used with at-home dialysis machines manufactured by NxStage.
NxStage Dialysis Fluid Recall
In May 2014, NxStage issued a recall for about 140,000-150,000 units of SAK Dialysis Concentrate after discovering high levels of aluminum. Although NxStage could not say how many users received the products, they were sold from April 2013 through February 2014.
The source of the problem was sodium lactate, a raw ingredient used in the dialysate concentrate. NxStage learned of the problem when their customers, Fresenius and DaVita dialysis clinics, found that patients who used NxStage at-home dialysis treatment had high levels of aluminum in their bloodstream.
According to NxStage:
“Specifically increases in patient serum aluminum levels averaging 10μg/L have been reported within specific dialysis networks. The aluminum levels of the affected lots range from 11.5 μg/L to 13 μg/L when the concentrate is fully diluted. The product specification requires concentrate aluminum levels to be less than 10 μg/L.”
Users Report Side Effects from NxStage Dialysis Fluid
In June 2014, an investigation by the Boston Globe discovered that some users reported feeling anemic and ill after being treated with NxStage dialysis concentrate. Some of them had aluminum levels that were two, three, or even four times higher than normal.
Aluminum Toxicity
Aluminum toxicity is a common problem for people undergoing hemodialysis. Every day, people normally ingest small amounts of aluminum from household products, deodorant, and foods. For people with kidney failure, aluminum levels can increase significantly over time. Hemodialysis does not effectively remove excess aluminum from the body.
Symptoms
High levels of aluminum can cause memory loss, dementia, bone disease, encephalopathy, anemia, and neurological disorders. Symptoms of this condition are often vague, but may include:
- Confusion
- Muscle weakness
- Bone pain, deformities, and fractures
- Seizures
- Speech problems
- And more
Do I have a NxStage Dialysis Lawsuit?
The Schmidt Firm, PLLC is currently accepting NxStage dialysate induced injury cases in all 50 states. If you or somebody you know was injured by aluminum poisoning, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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