Device recall
Z-0586-2026: IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing…
FDA device recall · Class I · Fresenius Kabi USA, LLC
Key facts
| Recall number (Z-number) | Z-0586-2026 |
|---|---|
| Recall event | 97941 |
| Product | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. |
| Product code | FRN |
| Recalling firm | Fresenius Kabi USA, LLC |
| Recall class | Class I |
| 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