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Outset Medical, Inc. Recalls Tablo Hemodialysis System for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA

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

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these affected devices may cause serious injuries, serious health consequences, or death. Please be aware, this recall is a correction, not a product removal.

Questions?

Customers with questions should contact Outset’s Technical Support team (844-MYTABLO or 844-698-2256).