FDA Device recall Z-0586-2026
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
- FDA Device
- Class I
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class I recall of IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25) by Fresenius Kabi Usa, citing incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0586-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-11-03 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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.
Reason
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Identifiers
| code_info | Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0586-2026%22
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