Drug recall
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring…
FDA recall event 86604 · Class II · Invacare Corporation
Key facts
| Event ID | 86604 |
|---|---|
| Recall numbers | Z-0514-2021 |
| Recalling firm | Invacare Corporation |
| Product type | Devices |
| Products | Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing… |
| Initiation date | Oct 30, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Dec 31, 2024 |
| City | Elyria |
| State | OH |
| Country | United States |
| FEI number | 1525712 |
At a glance
- 1–9 Products in this recall
- 10–99 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: