Z-1869-2025Class I

IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter...

Name: Z-1869-2025 IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter...
Creator: Fresenius Kabi USA, LLC
Published: 2025-05-12
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-05-12 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Kabi USA, LLC began a recall of IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set on 2025-05-12. FDA classified it as Class I and gives the reason as "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". 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-1869-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-12
Posted: 2025-06-06
Recalling firm: Fresenius Kabi USA, LLC
Product: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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 [email protected].
Quantity in commerce: 14,280 units (724 cases)
Distribution: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
Product codes and lots: Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1869-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06

Product code FPA

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)