Fresenius Medical Care is recalling certain hemodialysis machines due to a potential issue with silicon tubing that can expose patients to hazardous chemicals.
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 Aug. 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). There have been a total of 207 devices recalled in the US so far.
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.
The FDA has identified this as a Class I recall, the most serious type of recall, indicating that use of these devices may cause serious injuries or death. There have been no reports of death related to the recall.
Recalled Fresenius products include:
- Product Names: 2008 Series Hemodialysis Machines
- Product Codes and Model Numbers:
- 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
On Sept. 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.