Ivenix Infusion Pump Software Recalled for Potential Malfunctions
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
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 requires a minimum severity score of 4 per the rubric. The source describes software anomalies with potential to cause serious patient harm or death, but does not report any known fatalities or confirmed hospitalizations, resulting in a Severe classification.
Plain-English summary
The Ivenix Infusion System (IIS) LVP Software, Version 5.9.1 and prior, is being recalled by Fresenius Kabi USA, LLC. This software controls an infusion pump used to manage medication delivery in healthcare settings.
The software contains anomalies that can cause alarms, pump malfunctions, or unresponsive screens while the pump continues to deliver therapy. These anomalies have the potential to cause serious patient harm or death.
Approximately 17 units of the affected software have been distributed nationwide in the United States.
If you have used or have access to the Ivenix Infusion System with this software version, contact Fresenius Kabi USA, LLC immediately. Healthcare facilities should review the FDA recall notice for complete information and guidance.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
- Manufacturer
- Fresenius Kabi USA, LLC
- 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)
- UDI-DI: 00811505030122
- Software Version 5.9.1 and prior
Distribution
Distributed nationwide across the United States.
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