Drug recall
Ivenix Infusion System (IIS)
FDA recall event 90314 · Class II · Ivenix, Inc.
Key facts
| Event ID | 90314 |
|---|---|
| Recall numbers | Z-1381-2022 |
| Recalling firm | Ivenix, Inc. |
| Product type | Devices |
| Products | Ivenix Infusion System (IIS) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. |
| Initiation date | Apr 22, 2022 |
| Report date | Jul 20, 2022 |
| Termination date | May 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: