Ivenix Infusion System Software Recalled for Potential Dosing Anomalies
Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity floor of 4. The software anomalies create potential for serious patient harm through medication dosing errors. However, no actual deaths or reported illnesses are documented in the source, preventing a higher score of 5.
Plain-English summary
Fresenius Kabi USA, LLC is recalling the LVP Software of the Ivenix Infusion System (IIS), version 5.8.0, a medical device component used in infusion therapy delivery systems. Affected units are identified by product code LVP-SW-0004 and UDI-DI 00811505030122.
The software contains anomalies that have the potential to cause underdose, overdose, or delay in therapy. These dosing errors could lead to serious patient harm or death, prompting the FDA Class I recall.
The 17 affected units were distributed across 13 US states: California, Colorado, Idaho, Michigan, Nebraska, New Jersey, Nevada, Oklahoma, Texas, Utah, Virginia, Washington, and Wisconsin. Patients and healthcare providers in these states should verify whether their system contains the recalled software version.
The recalled product
- Product
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion System
- Affected units
- 17
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 (2)
- Product LVP-SW-0004
- UDI-DI 00811505030122.
Distribution
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