Drug recall
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
FDA recall event 82393 · Class I · Vyaire Medical
Key facts
| Event ID | 82393 |
|---|---|
| Recall numbers | Z-1385-2019, Z-1386-2019 |
| Recalling firm | Vyaire Medical |
| Product type | Devices |
| Products | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions., enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. |
| Initiation date | Mar 13, 2019 |
| Report date | Jul 3, 2019 |
| Termination date | Sep 22, 2020 |
| City | Mettawa |
| State | IL |
| Country | United States |
| FEI number | 3013421741 |
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: