FDA Medical devices recall ·
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1019-2025
- Date
- (initiated January 10, 2025)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 23 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Why was it recalled?
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00811505030122. Software 5.9.2 and prior
Distribution
US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
States: California Colorado Georgia Idaho Michigan Mississippi Nebraska New Jersey Nevada Oklahoma Texas Utah Virginia Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1019-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.