Ivenix Infusion System Set (Fresenius Kabi) – Filter Positioning (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 Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Model No. SET-0014-20, UDI 20811505030034, Lot No. FA24K05015.
Products Sold
Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.
Fresenius Kabi USA, LLC is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh due to Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Recommended Action
Per FDA guidance
Consignees received an "URGENT - VOLUNTARY RECALL" notification via email dated 5/11/25. This notification instructs consignees to discontinue use and distribution of affected devices immediately. Consignees are to check their inventory for affected devices and place them in quarantine until product can be returned for replacement. The provided recall notification is to be distributed to users of the affected devices. Consignees are instructed to return the completed Customer Reply Form via fax or email to facilitate return of affected devices for replacement. Consignees with any questions can contact Fresenius Kabi by phone at 855-354-6387x1 or by email at Ivenix_support@fresenius-kabi.com.
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 noticeDistribution
As reported by FDA
CA, CO, DE, GA, IL, MD, MI, MN, MS, NV, NJ, NC, OK, SC, TX, VA, WA, WI
Page updated: Jan 10, 2026