Drug recall
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for…
FDA recall event 82194 · Class II · Fenwal Inc
Key facts
| Event ID | 82194 |
|---|---|
| Recall numbers | Z-1059-2019 |
| Recalling firm | Fenwal Inc |
| Product type | Devices |
| Products | Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The optional Vacuum Unit may stop working and display the failure message "Failure vacuum unit" during use. |
| Initiation date | Feb 11, 2019 |
| Report date | Apr 3, 2019 |
| Termination date | Jun 23, 2020 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3004548776 |
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: