CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Ivenix Infusion System (IIS), Large Volume Pump recalled
Fresenius Kabi USA is recalling Ivenix Infusion System (IIS), Large Volume Pump, distributed nationwide in the US. The recall was initiated on 3 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0378-2026
- FDA event ID
- 97554
- Recalling firm
- Fresenius Kabi USA, North Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Sep 2025
- FDA classified
- 28 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Sep 2025 | Recall initiated by company | |
| 28 Oct 2025 | Classified by FDA | +55 days |
| 5 Nov 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Product as listed by the FDA
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Where it was distributed
US Nationwide distribution in the state of Minnesota.
Questions about this recall
Why was it recalled?
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Which lots are affected?
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Where was it sold?
US Nationwide distribution in the state of Minnesota.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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