Drug recall
Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an…
FDA recall event 82793 · Class II · Inovo, Inc
Key facts
| Event ID | 82793 |
|---|---|
| Recall numbers | Z-2099-2019 |
| Recalling firm | Inovo, Inc |
| Product type | Devices |
| Products | Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. |
| Initiation date | Apr 26, 2019 |
| Report date | Aug 7, 2019 |
| Termination date | Apr 2, 2021 |
| City | Lehigh Acres |
| State | FL |
| Country | United States |
| FEI number | 3000719543 |
At a glance
- 1–9 Products in this recall
- 1–9 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: