IVENIX Infusion System (Fresenius Kabi) – incorrect assembly (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Product Code: SET-0032-25, UDI: 00811505030214, Lot No. FA25B03126.
Products Sold
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Fresenius Kabi USA, LLC is recalling IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, D due to Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Recommended Action
Per FDA guidance
An 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026