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.
