Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Potential issue that can cause the device to register "phantom" touches
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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-0378-2026
- Published
- November 5, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Fresenius Kabi USA, LLC
- Product type
- Medical devices
- Units affected
- 6 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Products covered by this recall
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Check your product
The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Serial number
On the rating plate, often next to the date of manufacture.
- 2318600378
- 2321600176
- 2333300359
- 24030
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 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- 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.
- If you are a facility, quarantine affected stock and log the correction.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
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?
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation. Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
How do I know if I have the recalled product?
The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.
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?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class I · last month
Fresenius Kabi USA, LLC Tyenne Injection, 400 mg/20 mL , 20 mL vial recall: Presence of particulate matter:An internal investigation at the firm found
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
-
Class I · 2 months ago
Fresenius Kabi USA, LLC Morphine Sulfate Injection, USP, 2 mg /mL recall: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
-
Class II · 3 months ago
Fresenius Kabi USA, LLC Naropin , 0.5%, 100 mg per 20 mL , Twenty-five recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
-
Class II · 3 months ago
Fresenius Kabi USA, LLC Xylocaine , 1%, 200 mg per 20 mL , 25 Multiple-Dose Vials recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
-
Class II · 3 months ago
Fresenius Kabi USA, LLC Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
-
Class II · 3 months ago
Fresenius Kabi USA, LLC Xylocaine , 1%, 500 mg per 50 mL , 25 Multiple-Dose Vials recall: Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products