Z-2224-2026Class I

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Name: Z-2224-2026 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Creator: Fresenius Kabi USA, LLC
Published: 2026-05-06
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2026-05-06 / Open, Classified / root cause: design

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 on 2026-05-06. FDA classified it as Class I and gives the reason as "Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2224-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-06
Posted: 2026-05-29
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Product code: FRN Pump, Infusion
Reason for recall: Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Root cause tag: design
FDA root cause: Device Design
Action: On May 6, 2026 URGENT - Medical Device Field Correction letters were sent to customers. Required Actions for Healthcare Providers 1. If a unit has been dropped or severely jarred, remove it from service, even if no damage is visible. 2. Once you have removed the pump from service, or if you have questions about whether to do so after a drop, please contact Fresenius Kabi customer support at [email protected] or (855) 354-6387. 3. Post enclosed Safety Tip Sheet, Proper Handling of the Ivenix Large Volume Pump (LVP) notice within your facilities to ensure that all ancillary staff are informed of this notification and trained on the action to remove any dropped or severely jarred devices from use. 4. Notify other users if applicable. If your facility distributes or transfers devices to other locations, notify all anticipated users of this correction.
Quantity in commerce: 18,444
Distribution: Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
Product codes and lots: Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2224-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2224-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code FRN

K183311Class IIIvenix Infusion System (IIS)Ivenix, Inc. / cleared 2019-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)