The Fresenius Medical Care 2008 Series haemodialysis machine recall has been issued with a class I label—the most serious type of recall—by the US Food and Drug Administration (FDA). The recall was initiated in late 2022, when concerns were raised over non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) leaching from some of the tubing used in the devices, but the FDA label was only recently applied earlier this month. The recall applies to multiple versions of the 2008 Series devices, which were sold between August 2008 and June 2022, including over 200 that were sold within the USA.
The reason that this recall—which is a correction, not a product removal—was issued is, as the FDA states in a letter issued in 2022, NDL PCBAs may leach from some peroxide-cured silicone tubing used as part of the hydraulics in the machine and dialysate lines. Despite the fact that the tubing does not come into direct contact with blood, the acids could reach the patient’s blood, leading them to be exposed to the toxic chemicals. Whilst the FDA does state in its letter that “there have been no reports of death”, patients that have used the affected machines could experience “endocrine dysfunction, liver issues, neurobehavioural changes, skin problems, and in male patients, infertility.”
Data that were provided by Fresenius indicates the amount of NDL PCBAs that are released decreases over the first month of routine clinical use, so the FDA advises healthcare providers to “consider using other alternative machines, including Fresenius machines that have been in routine clinical use for greater than a month, if any are available” to avoid interruptions or delays with patient treatment.
Fresenius has already taken action to ensure that no new device manufactured after October 2022 is sold with this tubing, replacing the peroxide-cured tubing with an FDA-approved platinum-cured alternative. It is also using this tubing in the recalled devices, meaning that they can be returned to use with these replacement parts.
