Recall Z-0586-2026 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
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.
| Date | Dec 3, 2025 (initiated Nov 3, 2025) |
| Status | Open, Classified |
| Reason | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. |
| Root cause | Process control |
| Action | 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 co |
| Quantity | 483 cases (12,075 eaches) |
| Distribution | US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |