The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The devices described in this recall are related to the ongoing evaluation announced in the Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers.
Please be aware, this recall is a correction, not a product removal.
- Product Names: 2008 Series Hemodialysis Machines
- Product Codes and Model Numbers:
- Distribution Dates: August 21, 2008 to June 6, 2022
- Devices Recalled in the U.S.: 207
- Date Initiated by Firm: November 25, 2022
The Fresenius Medical Care 2008 Series Hemodialysis Machines act as an artificial kidney. They are used for hemodialysis treatment to pump blood from a person’s body to remove toxins and excess water.
Reason for Recall
Fresenius Medical Care is recalling some of its 2008 Series Hemodialysis Machines because patients may be exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide cured silicone tubing used as part of the hydraulics in the machine and dialysate lines. Data provided by the manufacturer indicates that the amount of NDL PCBAs decreases over the first month during routine clinical use of the hemodialysis machine. Fresenius Medical Care is updating affected machines manufactured between August 21, 2008 and June 6, 2022 that contain chlorinated peroxide cured silicone tubing and may not have been used or may have been in use for less than 36 days (or 486 total hours).
The use of affected machines may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), and male infertility.
There have been no reports of death.
Who May be Affected
- People who receive hemodialysis support from 2008 Series Hemodialysis Machines between August 21, 2008 to June 6, 2022.
What to Do
On September 6, 2023, Fresenius Medical Care sent an Urgent Medical Device Correction letter to affected customers.
The letter instructed customers to:
- Contact Fresenius Medical Care if you have hemodialysis machines that contain chlorinated peroxide cured silicone tubing and may not have been used or may have been in use for less than 36 days (or 486 total hours). Fresenius Medical care is offering to update these machines to platinum cured silicone tubing free of charge.
- Do not take any action if you have purchased a new machine from Fresenius Medical Care after October 2022. These new machines are manufactured with the platinum cured silicone tubing.
Customers in the U.S. with questions about this recall, or to schedule your update should call Fresenius Medical Care at 1-800-227-2572.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.