NxStage has recalled dialysis concentrate because it may contain high levels of aluminum. NxStage says it did not harm anyone, but some users have reported anemia, feeling ill, and very high levels of aluminum in their blood. The tainted products were sold for nearly a year before being recalled in May 2014.
Need a Texas NxStage Dialysis Fluid Recall Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by aluminum poisoning, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is NxStage SAK Concentrate?
NxStage SAK Concentrate is a clear dialysis concentrate that contains essential electrolytes, buffer, and glucose. It is mixed with water to create the liquid dialysate solution. This fluid flushes wastes out of the blood of people with end-stage kidney failure who are undergoing hemodialysis. It is used with the NxStage Pureflow SL and NxStage System One, the only at-home dialysis machine on the market.
NxStage SAK Dialysate Fluid Recall
May 15, 2014 — NxStage Medical Inc. has recalled 140,000 to 150,000 units of SAK Dialysate Concentrate because they contain high levels of aluminum. The affected lots were manufactured from April 2013 through February 2014.
The company learned of the problem from customer complaints, including Fresenius and DaVita clinics, who detected a small rise in blood-aluminum levels in patients receiving NxStage treatment.
The problem was traced to sodium lactate, a raw material used in the production of the SAK dialysate concentrate, which contained levels of aluminum that exceeded specification when the concentrate was diluted.
According to the recall:
“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.”
What is the problem?
NxStage says that no adverse health consequences have been reported. However, the Boston Globe investigated and found complaints from users who said the tainted fluid doubled, tripled, or even quadrupled their normal aluminum levels, causing them to feel anemic and sick.
Aluminum toxicity is a problem for people on hemodialysis because the process does not remove excess aluminum from the body, which can cause aluminum levels to build up over time. Aluminum toxicity can cause memory loss, bone disease, anemia, and dementia. People on dialysis are especially vulnerable because the kidneys do not excrete the metal.
- Muscle weakness
- Bone pain, deformities, and fractures
- Speech problems
Dialysis encephalopathy is a syndrome that is often attributed to aluminum toxicity. Other complications include:
- Lung problems
- Nervous system problems causing difficulty with voluntary and involuntary actions
- Bone diseases
- Brain disorders
- Impaired iron absorption
- And more
Need a NxStage Dialysis Fluid Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
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