Fresenius Medical Care’s Hemodialysis Machine Recall Due to Toxic Compound Exposure
The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most severe category of recalls indicating potentially life-threatening consequences, for some hemodialysis machines produced by Fresenius Medical Care. This recall is linked to an ongoing evaluation regarding the potential risks of exposure to toxic compounds in certain Fresenius-manufactured hemodialysis machines.
These machines, identified under the umbrella term “2008 Series Hemodialysis Machines,” function as artificial kidneys, crucial for drawing blood from patients, purifying it by eliminating excess water and toxins and then returning it to the patient’s body. They are indispensable in hemodialysis treatment.
The affected models include:
- 2008T HD SYS. W/O CDX BLUESTAR
- 2008T HD SYS. CDX W/BIBAG BLUESTAR
- 2008T HD SYS. CDX BLUESTAR
- 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
- 2008T Hemodialysis SYS, with CDX
- 2008T Hemodialysis System without CDX
- 2008T Hemodialysis System w/Bibag
- 2008T GEN 2 Bibag without CDX
However, Fresenius Medical Care has pinpointed a concerning issue: these machines may expose patients to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs). This toxic exposure is a result of certain silicone tubing components used in the machine’s hydraulics and dialysate lines. While the data suggests that the concentration of NDL PCBAs decreases over the first month of the machine’s clinical use, the potential consequences for patients exposed prior to this decline are severe. These include, but are not limited to, hormonal imbalances, liver complications, behavioral changes, skin conditions, and even male infertility.
Given the seriousness of this issue, patients undergoing hemodialysis treatment with these machines need to be particularly cautious. Fortunately, no deaths have been reported thus far. To address this, Fresenius Medical Care dispatched an Urgent Medical Device Correction letter in September 2023. They have urged facilities with the problematic machines to get in touch for free updates to safer, platinum-cured silicone tubing.
Legal Recourse for Victims of Fresenius Hemodialysis Machines
For those adversely impacted by these machines, there’s a legal path forward. Our product liability laws are designed to ensure that manufacturers are held accountable for any harm their products might cause. Any individual who has suffered due to the defective design of these hemodialysis machines can file a lawsuit to seek compensation.
Such a lawsuit can pursue compensation for damages such as:
Medical Expenses: Covering treatment costs that arose due to complications from the toxic exposure.
Lost Earnings: Any salary or wages lost due to illnesses or the inability to work post-exposure.
Pain and Suffering: Compensation for the physical and emotional trauma endured as a result of the exposure.
Punitive Damages: In instances where a company’s negligence is especially grievous, courts might award punitive damages. These are intended not just as compensation but as a stern financial deterrent, discouraging similar future negligence.
Seek Legal Advice from Parker Waichman LLP
If you or a loved one have undergone treatment with one of these recalled Fresenius hemodialysis machines and have subsequently faced severe health issues, you might have a case. Parker Waichman LLP, a prominent national product injury law firm, stands ready to assist. With a stellar reputation for defending the rights of victims, our firm offers a free consultation to evaluate your case. Don’t wait; seek justice now. Call 1-800-YOUR-LAWYER (1-800-968-7529) today and get the guidance you need.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
.svg){kind=small}
.avif)
.avif)