Drug recall
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
FDA recall event 84381 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 84381 |
|---|---|
| Recall numbers | Z-0800-2020 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its… |
| Initiation date | Nov 27, 2019 |
| Report date | Jan 22, 2020 |
| Termination date | May 28, 2024 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2015691 |
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: