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According to Nephrologynews.com, the U.S. Food and Drug Administration (FDA) said last week that it has received one report of death that may be related to the use of recalled lots of Fresenius North America’s NaturaLyte liquid bicarbonate concentrate.
Additionally, the FDA said that it has received two injury reports.
“This week, subsequent to the recall, the FDA updated its website with information that it received,” Jon Stone, spokesperson for Fresenius Medical Care said, according to Nephrologynews.com. “We are looking into these reports.”
Fresenius announced the voluntary recall in May of 56 lots of NaturaLyte liquid bicarbonate concentrate, a product used in hemodialysis machines.
The recalled products were reportedly discovered to have higher levels of bacteria than is allowed by its internal specifications.
People or clinics who received the product lots are being asked to discontinue use and contact Fresenius.
Additionally, machines that used the product should have a heated disinfection performed.
Have You Had a Family Member Killed or Injured By a Fresenius Product?
Fresenius has a history of product issues, including that of GranuFlo, a treatment for patients with late-stage kidney failure.
A study done by Fresenius evaluating patients in 667 dialysis centers revealed that patients were six to eight times more likely to suffer sudden cardiac death if they had elevated bicarbonate levels stemming from product usage.
If you or someone you love has suffered cardiac arrest while undergoing dialysis treatment, contact us today.
We can investigate your case and seek compensation if a defective product harmed you or your loved one.
Zoll & Kranz – GranuFlo attorneys
ZKB’s ‘Did You Know’? Class I recalls involve a high probability that use of the recalled product will cause serious adverse health consequences.
Source: https://www.healio.com/news/nephrology/20180226/fda-says-recalled-naturalyte-may-have-led-to-dialy
Michelle Kranz is a founding partner of Zoll & Kranz, located in Toledo, Ohio. Michelle has practiced as a plaintiff's lawyer for over 32 years, representing Ohioans injured in car accidents, other auto accidents, and other personal injury matters. Michelle also has extensive experience with large-scale consolidated litigation and class actions involving medical devices, prescription medications, and corporate negligence.
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Zoll & Kranz, LLC and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio injury lawyer, Michelle L. Kranz, you can do so here.
Zoll & Kranz, LLC does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
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