FDA-Device2022-11-23Class II
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
DeVilbiss Healthcare LLC
Hazard
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Sold states
US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Affected count
48 units
Manufactured in
100 Devilbiss Dr, N/A, Somerset, PA, United States
Products
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2023Don't want to check this manually?
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