Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall LVP Primary Administration Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall LVP Primary Administration Setsee related information
Date Initiated by FirmNovember 03, 2025
Date PostedDecember 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0586-2026
Recall Event ID 97941
510(K)NumberK183311 
Product Classification Pump, infusion - Product Code FRN
ProductIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Code Information Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
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		Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
FDA Determined
Cause 2		Process control
ActionAn URGENT - Voluntary Recall notice dated 10/30/25 was emailed to consignees. Consignees are instructed to discontinue use and distribution of affected devices immediately; check inventory and quarantine all affected devices. The recall notification is to be shared with users and inventory replaced with unaffected stock. Consignees with no affected devices are to complete and return the provided response form. Consignees with affected devices are to either destroy or return affected devices; replacements can be requested by contacting Fresenius Kabi Customer Service at 855-354-6387 (x1). If consignees destroy product, Fresenius Kabi will provide a Certificate of Destruction which must be completed and returned. Consignees with any questions are to email Ivenix_support@fresenius-kabi.com or call 855-354-6387.
Quantity in Commerce483 cases (12,075 eaches)
DistributionUS Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & 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
-
-