Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviro
Summary
The FDA issued a Class I for Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in by Fresenius Kabi USA, LLC. Reason: 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 a.
Details
Source
Device Recall
External ID
Z-1019-2025
Action Date
2025-02-12
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI: 00811505030122. Software 5.9.2 and prior
Quantity Affected: 23 systems
Reason for Recall
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.
Distribution
US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-10
Company
North Andover, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1019-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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