IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25).
Summary
The FDA issued a Class I for IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, by Fresenius Kabi USA, LLC. Reason: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury..
Details
Source
Device Recall
External ID
Z-0586-2026
Action Date
2025-12-10
Status
Ongoing
Category
device
Product Description
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Lot/Code Info: Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Quantity Affected: 483 cases (12,075 eaches)
Reason for Recall
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Distribution
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-03
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 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 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-0586-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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