Outset Medical recalls certain Tablo Hemodialysis Systems

Outset Medical, Inc., is recalling certain Tablo Hemodialysis System after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching were identified at levels above allowable safety limits. The NDL-PCBAs are coming from the peroxide cured silicone tubing used as a part of the machine’s hydraulics and for the dialysate lines. Patients may be exposed to higher than allowable limits of these NDL-PCBA compounds via the dialysate solution.

Outset Medical, Inc., determined that NDL- PCBAs leaching decreases over time, and that NDL-PCBAs reduce to an acceptable safety level after 336 hours of console operational use. This recall is aimed at changing the affected tubing for consoles that have been in use for less than 336 hours.

NDL-PCBAs are an acid of NDL-PCBs. Exposure to NDL-PCBs or NDL-PCB related compounds 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.

Outset Medical, Inc., reports no injuries or deaths related to this issue.

Who may be affected

• Patients who currently receive dialysis with the Tablo Hemodialysis System and those who may receive care using the system in the near future.
• Health care providers who use the Tablo Hemodialysis System to care for patients.

U.S. Food and Drug Administration