Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Summary
The FDA issued a Class I for Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 by Fresenius Kabi USA, LLC. Reason: Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components t.
Details
Source
Device Recall
External ID
Z-2224-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Lot/Code Info: Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
Quantity Affected: 18,444
Reason for Recall
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Distribution
Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-06
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 169 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-2224-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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