Fresenius recalls dialysis machines for possible exposure to toxic compounds in tubing
Click Here to Manage Email Alerts
Key takeaways:
- Fresenius Medical Care has recalled some dialysis machines because patients may be exposed to toxic compounds in tubing used in the equipment.
- The tubing is used in earlier models of the 2008 Series hemodialysis machines.
Fresenius Medical Care is recalling some 2008 Series hemodialysis machines because non-dioxin-like polychlorinated biphenyl acid may be leaching from the silicone tubing used in the machines, according to an FDA press release.
The FDA has identified this as a class 1 recall, the most serious type of recall. Use of these devices may cause serious injuries or death, according to the release.
“Data provided by the manufacturer indicates that the amount of [non-dioxin-like polychlorinated biphenyl acids] NDL PCBAs decreases over the first month during routine clinical use of the hemodialysis machine,” the FDA said.
Fresenius is replacing the tubing on the 2008 Series hemodialysis machines manufactured prior to October 2022; the FDA estimates there are 207 dialysis machines as part of the recall.
“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,” according to the FDA release.
“There have been no reports of death.”
Read more about
Click Here to Manage Email Alerts