Device recall
Z-2635-2023: Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1…
FDA device recall · Class II · Fresenius Kabi USA, LLC
Key facts
| Recall number (Z-number) | Z-2635-2023 |
|---|---|
| Recall event | 92973 |
| Product | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration. |
| Product code | FRN |
| Recalling firm | Fresenius Kabi USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183311 |
| FEI number | 3014732157 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database