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U.S. Department of Health and Human Services

Class 2 Device Recall Ivenix Infusion System (IIS), Large Volume Pump

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 Class 2 Device Recall Ivenix Infusion System (IIS), Large Volume Pumpsee related information
Date Initiated by FirmSeptember 03, 2025
Date PostedOctober 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0378-2026
Recall Event ID 97554
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. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Recalling Firm/
Manufacturer		 Fresenius Kabi USA, LLC
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information Contact
978-775-8050
Manufacturer Reason
for Recall		Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA Determined
Cause 2		Process change control
ActionFresenius Kabi notified the consignee on 09/03/2025 via email. The consignee was instructed to review the list of affected units and identify any on hand for return, remove all affected units from circulation pending repair and isolate them to avoid use, notify customers/personnel if the units were further distributed or transferred, and ensure all relevant personnel are aware. A Fresenius Kabi service representative will contact the consignee arrange for the return of affected units for repair.
Quantity in Commerce6 units
DistributionUS Nationwide distribution in the state of Minnesota.
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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