Infusion system software recalled to emphasize instructions in the manual
Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the action re-emphasizes existing instructions for use, with no device defect or stated consequence.
Plain-English summary
The Ivenix Infusion System (IIS), LVP Software LVP-SW-0005, is being recalled by Fresenius Kabi USA, LLC.
The reason given in the enforcement record is emphasizing instructions for LVP duration programming located in the instructions for use.
The record lists 30 units under product code LVP-SW-0005, UDI 00811505030122, covering software versions 5.10.2 and prior. Distribution was nationwide in the United States, across California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin. The FDA has classified the action as Class II.
The record describes a communication that re-emphasizes existing instructions for use, and states no consequence or reported injuries. Facilities should follow Fresenius Kabi's instructions.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Code: LVP-SW-0005
- UDI: 00811505030122
- Software versions 5.10.2 and prior.
Distribution
Related recalls
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighNaropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · instructions for use
See all →- HighChest drainage units recalled to limit their use to adults
FDA (Devices) · 2026-02-04
- ModerateFoot plating systems recalled to remove a sterilization option from instructions
FDA (Devices) · 2025-10-29
- CriticalBF-H1100 bronchovideoscopes recalled for updated instructions on energy therapy equipment
FDA (Devices) · 2025-10-22
- CriticalBF-P60 bronchofiberscopes recalled for updated instructions on laser and coagulation use
FDA (Devices) · 2025-10-22
- CriticalBF-Q180-AC bronchovideoscopes recalled for updated laser and coagulation use instructions
FDA (Devices) · 2025-10-22
Similar recalls
- CriticalInfusion pump software recalled over anomalies that could cause serious harm
FDA (Devices) · 2025-12-24
- SevereIvenix Infusion System Software Recalled for Potential Dosing Anomalies
FDA (Devices) · 2024-04-17
- SevereIvenix Infusion Pump Software Recalled for Potential Malfunctions
FDA (Devices) · 2024-10-02
- HighIvenix Infusion System Software Defect May Delay or Cause Incorrect Infusions
FDA (Devices) · 2024-03-20
- SevereIvenix Infusion System LVP Software Display May Freeze Unresponsive
FDA (Devices) · 2022-10-12
- HighIvenix Infusion System Software Startup Delays in Certain Flow Rate Ranges
FDA (Devices) · 2023-10-04