Z-0586-2026Class I

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual...

Name: Z-0586-2026 IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual...
Creator: Fresenius Kabi USA, LLC
Published: 2025-11-03
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-11-03 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Kabi USA, LLC began a recall of IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump... on 2025-11-03. FDA classified it as Class I and gives the reason as "Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0586-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-11-03
Posted: 2025-12-03
Recalling firm: Fresenius Kabi USA, LLC
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.
Product code: FRN Pump, Infusion
Reason for recall: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 483 cases (12,075 eaches)
Distribution: US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Product codes and lots: Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0586-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0586-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-03

Product code FRN

K183311Class IIIvenix Infusion System (IIS)Ivenix, Inc. / cleared 2019-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)