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DeVilbiss Healthcare LLC recalls 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 12
Recalled November 23, 2022 · FDA recall Z-0229-2023 · DeVilbiss Healthcare
Hazard
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) · FDA Class II
Units
48 units
Sold at
US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Description
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Product
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Manufacturer(s)
DeVilbiss Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →