Fresenius Kabi Usa, Llc: Pump, Infusion
Recall Summary The Ivenix Infusion System (IVP-0004) large volume pump is being recalled because dropping or jarring the device can damage internal components invisibly, potentially loosening the touchscreen cable. This damage can cause the touchscreen to respond unpredictably, registering random touches or failing to respond to intentional user input. The affected devices were distributed across multiple U.S. states.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Reason
- 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...
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-06
- Status
- Open, Classified
- Areas affected
- CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, MO, NE, ...
- 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;
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/019cc543-24ce-407a-85cc-5d8c9d008030