FDA Device recall Z-1283-2024
LVP software of the Ivenix Infusion System (IIS)
- FDA Device
- Class II
- completed
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of LVP software of the Ivenix Infusion System (IIS) by Fresenius Kabi Usa, citing retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is execu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1283-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-05-10 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Reason
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Identifiers
| code_info | UDI-DI 00811505030122 Software versions 5.2.1/5.2.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Other recalls by Fresenius Kabi Usa
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
FDA Drug · Class I · 2026-09-02 · Fresenius Kabi Usa - Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…
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-1283-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.