125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Reported: November 23, 2022 Initiated: September 19, 2022 #Z-0229-2023
Product Description
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
Reason for Recall
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Details
- Recalling Firm
- DeVilbiss Healthcare LLC
- Units Affected
- 48 units
- Distribution
- US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
- Location
- Somerset, PA
Frequently Asked Questions
What product was recalled? ▼
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB. Recalled by DeVilbiss Healthcare LLC. Units affected: 48 units.
Why was this product recalled? ▼
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0229-2023.
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