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Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs

Baxter is correcting 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 is in the process of 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 U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This recall involves correcting devices, and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without correction.

Questions?

Customers in the U.S. with questions about this recall should contact Baxter Renal Customer Care at 800-525-2623, press option 2, then press option 2 again.