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U.S. Department of Health and Human Services

Class 2 Device Recall Ivenix Infusion System (IIS)

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 Class 2 Device Recall Ivenix Infusion System (IIS)see related information
Date Initiated by FirmNovember 21, 2025
Date PostedJanuary 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1048-2026
Recall Event ID 98106
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductIvenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Code Information Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
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		Emphasizing instructions for LVP duration programming located in the IFU.
FDA Determined
Cause 2		Use error
ActionAn URGENT MEDICAL DEVICE CORRECTION notification dated 11/21/25 was sent to consignees notifying them of this safety alert. The notification reiterates instructions for administering infusions included in the device's IFU. Fresenius Kabi asks consignees to disseminate the notification to all users and any facilities where devices may have been further distributed for their awareness. Consignees with any questions are to contact Customer Support by email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.
Quantity in Commerce30 units
DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, 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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