Baxter Recalls AK 98 Dialysis Machines

Baxter is recalling (Class 1 device correction) its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. Baxter says it is “evaluating whether the source of PCBAs and/or NDL PCBs in those recalls (the silicone tubing manufacturing process using a chlorinated peroxide initiator) is present in AK 98 dialysis machines.” The company is also transitioning certain components in the devices from peroxide-cured silicone tubing to platinum-cured silicone tubing, a recall notice says, adding that the suspect chemicals are not detected in medical devices with this modified silicone tubing.

“The use of affected product may cause serious adverse health consequences months to years after exposure, including endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), male infertility, and death,” the notice says. To date,  there have been no reported injuries or deaths.