Z-2234-2025Class II

LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25)

Name: Z-2234-2025 LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25)
Creator: Fresenius Kabi USA, LLC
Published: 2025-06-24
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Kabi USA, LLC began a recall of LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25 on 2025-06-24. FDA classified it as Class II and gives the reason as "Potential for external cassette leaks". 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-2234-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-24
Posted: 2025-08-01
Recalling firm: Fresenius Kabi USA, LLC
Product: LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Product code: FRN Pump, Infusion
Reason for recall: Potential for external cassette leaks
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Fresenius Kabi notified consignees on about 06/24/2025 via telephone call and followed up with a letter. Consignees were instructed to discontinue use and distribution immediately, quarantine any affected units on hand, notify users of the issue, and complete and return the Customer Reply Form. If affected units were further distributed, consignees were instructed to notify those customers. If Affected units were on hand, consignees were instructed to either destroy or arrange for their return. Replacement of affected units can be arranged.
Quantity in commerce: 35,925 units
Distribution: US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Product codes and lots: Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146, FA24K25153.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2234-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2232-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2233-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2234-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2235-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31

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)