Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Summary
The FDA issued a Class II for Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. by Fresenius Kabi USA, LLC. Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set..
Details
Source
Device Recall
External ID
Z-0848-2026
Action Date
2025-12-10
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.
Quantity Affected: 15,862 units
Reason for Recall
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Distribution
US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-03
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 336 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-0848-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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