Ivenix Infusion System recallZ-0586-2026 · Fresenius Kabi USA, LLC · initiated Nov 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
FDA root cause category: Process control
What the company is doing
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 [email protected] or call 855-354-6387.
Recall details
- Recall number
- Z-0586-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 3, 2025
- Posted by the FDA
- Dec 3, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 483 cases (12,075 eaches)
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Product description
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.
Code information (models, lots, serial numbers)
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix Infusion System SET-0032-1Fresenius Kabi AG · Set, Administration, Intravascular2 recalls396 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Ivenix Infusion System LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
- Ivenix Infusion System 030-0028-08Fresenius Kabi AG · Pump, Infusion7 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
- Ivenix Infusion System 030-0028-07Fresenius Kabi AG · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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