The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Summary
The FDA issued a Class II for The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: L by Fresenius Kabi USA, LLC. Reason: Potential for the Cassette Loading Lever to break..
Details
Source
Device Recall
External ID
Z-2274-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Lot/Code Info: Model Number: LVP-0004. UDI-DI: 00811505030320
Quantity Affected: 18,444 installed bases
Reason for Recall
Potential for the Cassette Loading Lever to break.
Distribution
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-04
Company
North Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-2274-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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