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:
- Document health issues related to dialysis machine use.
- Gather medical records and evidence of treatments.
- Contact a lawyer specializing in medical device litigation.
- Follow guidance from healthcare professionals.
- 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.
