Recall Z-0848-2026 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
| Date | Dec 1, 2025 (initiated Nov 3, 2025) |
| Status | Open, Classified |
| Reason | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. |
| Root cause | Labeling design |
| Action | Fresenius Kabi notified consignees on about 11/03/2025 via emailed letter. Consignees were informed of the issue and instructed to account for additional backpressure if check valve is used when configuring the downstream occlusion pressure alarm setting, adjust the occlusion alarm pressure to allow for a more balanced approach between occlusion detection and avoidance of unnecessary alarms, and continue to follow all Instructions for Use and institutional policies regarding infusion pump setup, monitoring, and alarm response. Consignees were requested to ensure all relevant persons within th |
| Quantity | 15,862 units |
| Distribution | US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |