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U.S. Department of Health and Human Services

Class 2 Device Recall The Large Volume Pump of the Ivenix Infusion System

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 Class 2 Device Recall The Large Volume Pump of the Ivenix Infusion Systemsee related information
Date Initiated by FirmFebruary 04, 2026
Date PostedMay 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2274-2026
Recall Event ID 98699
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductThe Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Code Information Model Number: LVP-0004. UDI-DI: 00811505030320
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
978-775-8050
Manufacturer Reason
for Recall		Potential for the Cassette Loading Lever to break.
FDA Determined
Cause 2		Device Design
ActionFresenius Kabi notified consignees on about 02/04/2026 via letter. Consignees were informed of the lever breakage and that two potential sources of the breakage were: 1. If the Cassette Loading Lever is left open during transport, it can be damaged if it is jarred by another object or surface. 2. Applying force to a locked Loading Lever when it is in the locked position can result in potential damage and/or cause it to break. Consignees were reminded of proper Loading Lever handling: 1. Do not force the Cassette Loading Lever open or closed. The lever does not require significant force to operate, and excessive force can damage the LVP. Excessive force can damage the LVP and prevent use. 2. The Cassette Loading Lever does not require excessive force to load or unload the administration set. 3. If the Cassette Loading Lever does not move with minimal force, do not continue to apply force. Check that the pump is not currently infusing and verify there are no obstructions. 4. When an infusion completes or is paused, the flow dial may take up to 5 seconds to close and unlock the Cassette Loading Lever. Consignees were also reminded of proper transport and storage to ensure the Cassette Loading Lever is fully closed prior to moving, transporting, or storing the pump, and after transport, visually confirm the Cassette Loading Lever is intact and moves freely before clinical use. Additionally, consignees were requested to complete and return the Customer Reply Form provided.
Quantity in Commerce18,444 installed bases
DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, 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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