Z-1313-2023Class I

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Name: Z-1313-2023 Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Creator: Fresenius Kabi USA, LLC
Published: 2023-03-10
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2023-03-10 / Open, Classified / root cause: manufacturing process

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 on 2023-03-10. FDA classified it as Class I and gives the reason as "Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion". 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-1313-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-03-10
Posted: 2023-04-18
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Product code: FRN Pump, Infusion
Reason for recall: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm distributed via email a URGENT - Medical Device Recall notification to consignees identifying all large volume pumps (LVP) of the Ivenix Infusion System as requiring repair or replacement due to potential fluid ingress, which could lead to interrupted infusion of medication. Customers are instructed to have a secondary LVP readily available when the device is being used to deliver life-sustaining medication if the provided troubleshooting instructions do not resolve the cessation of infusion. Additionally, customers are to ensure no buildup of liquid on the Air Detector region surfaces by wiping away any fluid buildup and reloading the cassette if the LVP exhibits an alert. Additional instructions were provided based upon varying clinical situations and should be posted above each nursing station where the device is in use. Fresenius will be contacting their customers to arrange service in response to this recall event. Adverse events or quality problems should be reported to Fresenius at [email protected]. Customers are asked to return the Customer Reply Form provided with the recall notification and to forward the recall notice to any customers/satellite locations at which recalled devices were further distributed.
Quantity in commerce: 1,546 units
Distribution: Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
Product codes and lots: UDI-DI: 00811505030320; Serial No.: 2118200008, 2118200011, 2119300411, 2119300412, 2119300414, 2119300415, 2119300416, 2119300417, 2119300418, 2119300421, 2119300422, 2119300424, 2119300426, 2119300427, 2119300428, 2119300429, 2119300430, 2119300431, 2119300432, 2119300434, 2119300435, 2119300436, 2119300437, 2119300438, 2119300439, 2119300440, 2119300442, 2124300049, 2124300051, 2124300052, 2124300053, 2124300054, 2124300058, 2124300059, 2124300060, 2124300061, 2124300062, 2124300063, 2124300064, 2124300065, 2124300066, 2124300068, 2124300069, 2124300070, 2124300072, 2124300074, 2124300075, 2124300076, 2124300077, 2124300078, 2124300080, 2124300082, 2124300083, 2124300084, 2124300085, 2124300086, 2124300087, 2124300089, 2124300090, 2124300091, 2124300093, 2124300094, 2124300096, 2124300097, 2124300099, 2124300100, 2124300101, 2124300102, 2124300103, 2124300104, 2124300106, 2124300107, 2124300108, 2124300109, 2124300110, 2124300111, 2124300112, 2124300113, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1313-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1313-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-11

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)