FDA Medical devices recall ·
Ivenix Infusion System (IIS), Large Volume Pump recall
- Recall number
- Z-0378-2026
- Date
- (initiated September 3, 2025)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Distribution
US Nationwide distribution in the state of Minnesota.
States: Minnesota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0378-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.