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Fresenius Dialysis Machine Lawsuit [2024 Investigation]

Fresenius Medical Care Recalls Dialysis Machines Due to Serious Adverse Health Consequences

On this page, we’ll discuss the investigation into a potential Fresenius Dialysis Machine Lawsuit, why the FDA placed a Class I Recall on Fresenius Medical Care Dialysis Machines, and much more.

Fresenius Dialysis Machine Lawsuit Investigation

Fresenius Medical Care recalled their 2008 Series Hemodialysis Machines in early 2024 due to the risk of toxic compounds, specifically non-dioxin-like polychlorinated biphenyl acids (PCBAs), leaching from the machines’ silicone tubing.

This recall involves various configurations of the 2008T Hemodialysis System.

The FDA classified this as a Class I recall, highlighting the serious health risks, including liver damage, hormonal imbalances, and skin conditions.

Fresenius Dialysis Machine Lawsuit 2024 Investigation

Lawyers are currently investigating potential lawsuits against Fresenius Medical Care for individuals who have suffered health problems related to these machines.

If you or a loved one used a Fresenius Medical Care Dialysis Machine and subsequently suffered health complications, you may be eligible to file a claim.

Contact our law firm for a free consultation, or use the chatbot on this page to get in touch with our legal team today.

Medical devices are designed to be safe and free from health risks to ensure the well-being of patients and consumers.

It is crucial that individuals are protected from errors and defects that could harm their health.

Product liability lawyers specializing in medical device litigation strive to help injured people seek compensation for the damages they have suffered due to faulty medical devices.

Reach out to our law firm today for a free consultation.

We’re here to help you.

Table of Contents

Fresenius Medical Care Dialysis Machines Recall

Fresenius Medical Care recalled approximately 2 million dialysis devices due to a risk of toxin exposure.

The recall, classified as Class I by the FDA, addresses the leakage of non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) from the peroxide cured silicone tubing in the machines.

These toxic compounds can potentially cause serious adverse health consequences, including endocrine dysfunction, liver issues, neurobehavioral changes, and skin problems such as acne and rashes.

The affected machines include various models of the 2008 Series Hemodialysis Machines, distributed from August 21, 2008, to June 6, 2022.

Additionally, Stay-Safe Catheter Extension Sets and Stay-Safe Luer Lock Adapters used in peritoneal dialysis systems were also recalled due to similar risks.

Fresenius Medical Care has sent out an urgent medical device correction letter, advising customers to replace the faulty tubing with platinum cured silicone tubing.

The FDA has highlighted the significant health risks associated with the use of these machines and encouraged patients to report any adverse events.

Legal investigations are ongoing to assist individuals who have suffered health issues due to the defective dialysis machines.

Patients affected by the recall are urged to seek legal advice to explore their compensation options.

Our law firm conducts free and no-obligation consultations with any person who has suffered health problems after using a defective medical device.

Contact us today.

List of Affected Machines

The recall affects several models of the 2008 Series Hemodialysis Machines distributed between August 21, 2008, and June 6, 2022.

These machines are used in healthcare facilities to provide dialysis treatments for patients with chronic end stage kidney disease.

Below is a list of the specific models impacted by the recall:

  • 2008T Hemodialysis System without CDX
  • 2008T Hemodialysis System with CDX
  • 2008T Hemodialysis System with Bibag
  • 2008T HD SYS. W/O CDX Bluestar
  • 2008T HD SYS. CDX with Bibag Bluestar
  • 2008T HD SYS. CDX Bluestar
  • 2008T HD SYS. W/O CDX with Bibag Bluestar
  • 2008T GEN 2 Bibag without CDX

What Toxic Chemicals were Leaking from Fresenius Dialysis Machines?

The toxic chemicals leaking from chlorinated peroxide cured silicone tubes within Fresenius dialysis machines were non-dioxin-like polychlorinated biphenyl acids (PCBAs).

These chemicals originated from the peroxide cured silicone tubing used in the machines’ hydraulics and dialysate lines.

PCBAs are a group of man-made organic chemicals known for their use in various industrial applications due to their non-flammability, chemical stability, and insulating properties.

They are produced through the chlorination of biphenyl and can leach out of materials like silicone tubing under certain conditions.

The presence of PCBAs in dialysis machines poses a risk because these compounds can accumulate in the body over time, leading to serious adverse health consequences.

Their stability and fat-solubility mean they persist in the environment and within biological systems, making their exposure particularly hazardous.

Health Risks Associated with Fresenius Dialysis Machines

The health risks associated with Fresenius dialysis machines stem from the leakage of non-dioxin-like polychlorinated biphenyl acids (PCBAs) from the peroxide cured silicone tubing used in the machines’ hydraulics and dialysate lines.

These toxic compounds do not directly contact the blood but can back-filter through the dialyzer into the patient’s bloodstream during treatment.

Exposure to PCBAs has been linked to serious health issues, including endocrine dysfunction, liver problems, neurobehavioral changes, and male infertility.

Preliminary data suggest that the amount of PCBAs might decrease over the first month of clinical use, but additional testing is necessary to understand the degree and duration of exposure.

The FDA has classified this recall as Class I, indicating the highest level of risk, and is working with Fresenius Medical Care to collect more data and develop strategies to mitigate the exposure risk.

Steps to Take if You Have Been Affected

If you have been affected by the recalled Fresenius dialysis machines, it is important to take immediate action to protect your health and legal rights.

Document any health issues you have experienced that may be related to the use of these machines. Gather all relevant medical records and evidence of your dialysis treatments.

Contact a lawyer experienced in medical device litigation to discuss your case and potential compensation.

Follow any guidance provided by healthcare professionals and stay informed about updates from the FDA and Fresenius Medical Care.

Steps to take if you’ve been affected include:

  1. Document health issues related to dialysis machine use.
  2. Gather medical records and evidence of treatments.
  3. Contact a lawyer specializing in medical device litigation.
  4. Follow guidance from healthcare professionals.
  5. Stay informed about updates from the FDA and Fresenius Medical Care.

Fresenius Medical Care’s Response

Fresenius Medical Care has proactively responded to the recall by issuing an urgent medical device correction letter to all affected customers.

They advised replacing the faulty peroxide cured silicone tubing with platinum cured silicone tubing to mitigate the risk of exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs).

Fresenius has also placed a temporary distribution hold on new machines and parts using the faulty tubing and is working to transition all devices to the safer tubing.

The company is collaborating with the FDA to collect and evaluate data on the exposure risks.

Fresenius is conducting further testing to ensure the safety of their dialysis machines and has provided a contact line for customers seeking more information.

Legal Rights and Potential Compensation

Individuals affected by the recalled Fresenius dialysis machines may have legal rights to seek compensation for their health problems.

Potential lawsuits are being investigated to hold Fresenius Medical Care accountable for the exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) from their devices.

Compensation may cover medical expenses, lost wages, pain and suffering, and other related damages.

Affected patients should document their health issues and gather all relevant medical records.

Consulting with a lawyer experienced in medical device litigation is crucial to understand your legal options.

Legal teams are actively working to support those impacted by these defective dialysis machines.

TorHoerman Law: Investigating Recalled Fresenius Medical Care Dialysis Treatments

Exposure to PCBAs from these recalled devices may lead to adverse health consequences months to years after initial exposure.

Our law firm is currently investigating potential lawsuits for individuals who have suffered health issues due to the use of Fresenius dialysis machines.

We aim to help affected patients seek compensation for their injuries, covering medical expenses, lost wages, and other related damages.

Contact us today for a free, no-obligation consultation.

Frequently Asked Questions

  • What are the Fresenius Medical Care Dialysis Machines Used For?

    Fresenius Medical Care dialysis machines are primarily used for hemodialysis treatments in patients with chronic end stage kidney disease.

    These machines act as artificial kidneys, filtering and removing toxins, excess fluids, and waste products from the blood.

    In addition to hemodialysis machines, Fresenius also provides peritoneal dialysis systems.

    Peritoneal dialysis catheters are used to access the patient’s peritoneal cavity, allowing for the infusion and drainage of dialysate solution during peritoneal dialysis treatments.

    Both types of dialysis treatments are essential for managing kidney failure, improving patients’ quality of life, and extending their lifespan.

    Healthcare facilities rely on these machines to provide critical, life-sustaining treatments to patients with severe kidney conditions.

  • What Health Issues are Linked to the Recalled Fresenius Dialysis Machines?

    Exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs) from the recalled Fresenius dialysis machines can lead to serious health issues.

    These include endocrine dysfunction, liver problems, neurobehavioral changes, skin problems such as acne and rashes, and male infertility.

    The risk of these adverse health consequences underscores the importance of the FDA’s Class I recall and the need for patients to seek medical and legal advice.

    Treating patients with these machines requires vigilance and immediate response to any health issues.

  • What Actions Has Fresenius Medical Care Taken in Response to the Recall?

    Fresenius Medical Care has issued an urgent medical device correction letter to replace the faulty peroxide cured silicone tubing with platinum cured silicone tubing.

    The company has also placed a temporary distribution hold on new machines and parts using the faulty tubing and is working to transition all devices to the safer tubing.

    Fresenius Medical Care is collaborating with the FDA to collect and evaluate data on the exposure risks and conducting further testing to ensure the safety of their dialysis machines.

  • What Compensation Might Be Available for Affected Patients?

    Patients affected by the recalled Fresenius dialysis machines may seek compensation for various damages.

    Potential compensation could cover medical expenses, lost wages, pain and suffering, and other related damages.

    Consulting with a lawyer specializing in medical device litigation is essential to understand your legal options and pursue appropriate compensation.

Written By:
Tor Hoerman

Tor Hoerman

Owner & Attorney - TorHoerman Law

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