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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- underdose
- overdose
- therapy-delay
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
Distributed in 13 states:
- CA
- CO
- ID
- MI
- NE
- NJ
- NV
- OK
- TX
- UT
- VA
- WA
- WI
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