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U.S. Department of Health and Human Services

Class 1 Device Recall Ivenix Infusion System (IIS)

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 Class 1 Device Recall Ivenix Infusion System (IIS)see related information
Date Initiated by FirmMay 06, 2026
Date PostedMay 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2224-2026
Recall Event ID 98945
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Code Information Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
FEI Number 3014732157
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information ContactRebecca McCandless
847-393-5451
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce18,444
DistributionDomestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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