Drug recall
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA recall event 93958 · Class II · Fresenius Kabi USA, LLC
Key facts
| Event ID | 93958 |
|---|---|
| Recall numbers | Z-1282-2024 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Product type | Devices |
| Products | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a… |
| Initiation date | Sep 16, 2022 |
| Report date | Mar 20, 2024 |
| City | North Andover |
| State | MA |
| Country | United States |
| FEI number | 3014732157 |
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: