Fresenius Kabi USA, LLC Ivenix Infusion System, LVP Primary Administration Set recall: Incorrect assembly of specific lot of LVP Primary Administration Set
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0586-2026
- Published
- December 10, 2025
- Risk level
- Class I
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Fresenius Kabi USA, LLC
- Product type
- Medical devices
- Units affected
- 483 cases (12,075 eaches)
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
- UPC codes
- 00811505030214
Products covered by this recall
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.
Check your product
The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00811505030214
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- FA25B03126. — 483 cases
Model or item number
On the rating label, the box or the instruction sheet.
- SET-0032-25
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Fresenius Kabi USA, LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: Fresenius Kabi USA, LLC — 50 High St Ste 50, North Andover, MA, 01845-2620
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Fresenius Kabi USA, LLC medical devices recalled?
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00811505030214; lot code FA25B03126. — 483 cases; model number SET-0032-25. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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