Drug recall
125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models…
FDA recall event 90950 · Class II · DeVilbiss Healthcare LLC
Key facts
| Event ID | 90950 |
|---|---|
| Recall numbers | Z-0229-2023 |
| Recalling firm | DeVilbiss Healthcare LLC |
| Product type | Devices |
| Products | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) |
| Initiation date | Sep 19, 2022 |
| Report date | Nov 23, 2022 |
| City | Somerset |
| State | PA |
| Country | United States |
| FEI number | 2515872 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: