DeVilbiss Healthcare LLC recalls 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125…
- Recall date
- September 19, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0229-2023
- FDA classification
- Class II
- Brand / firm
- DeVilbiss Healthcare LLC
- Sold / distributed
- US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Why it was recalled
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
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