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

FDA device recall Z-2224-2026 · posted 2026-05-29 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

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.

Action taken

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 Ivenix_support@fresenius-kabi.com 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.

Root cause

Device Design

Status

Open, Classified

Product code

FRN

Quantity affected

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;

Date initiated

2026-05-06

Date posted

2026-05-29

Location

North Andover, MA

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