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.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- November 3, 2025
- Posted
- December 3, 2025
- Recall Number
- Z-0586-2026
- Quantity
- 483 cases (12,075 eaches)
- Firm Location
- North Andover, MA
Reason for Recall
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Distribution
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Lot / Code Info
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Root Cause
Process control
Action Taken
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.