FDA Device recall Z-1484-2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0
- FDA Device
- Class I
- ongoing
- Published 2024-04-17
On 2024-04-17 the FDA classified a Class I recall of LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0 by Fresenius Kabi Usa, citing software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1484-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-07 |
| Published | 2024-04-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, WI |
Product
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Reason
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Identifiers
| code_info | Product LVP-SW-0004; UDI-DI 00811505030122. |
|---|
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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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1484-2024%22
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