Z-2635-2023Class II

Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004...

Name: Z-2635-2023 Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004...
Creator: Fresenius Kabi USA, LLC
Published: 2022-04-22
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2022-04-22 / Open, Classified / root cause: design

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient... on 2022-04-22. FDA classified it as Class II and gives the reason as "Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2635-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-22
Posted: 2023-09-25
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Product code: FRN Pump, Infusion
Reason for recall: Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Root cause tag: design
FDA root cause: Device Design
Action: Ivenix initiated contact on 4/22/22/ via phone communicating the contents of the customer letter which was then emailed to each customer. Letter states reason for recall, health risk and action to take: Please note, the specified start-up flow accuracy of up to +8% is maintained throughout the extended start-up time; and the steady-state flow accuracy of +l-SYo of the LVP is not affected with this condition. There is no corrective action you need to take at this time. We believe that this condition is low risk in that the affected flow rate range is limited, the start'up flow rate accuracy is unaffected and still within specifications, and the clinical practice of monitoring patients while administering high alert drugs mitigates the risk. Ivenix is working on a software update to correct this condition. It will be available in approximately 60 days. We will inform you when that update is ready to install. If you have additional questions, please contact your Ivenix representative or support below. Customer support - email Customer support - phone [email protected] I-978-775-8TAA
Quantity in commerce: 1344 pumps
Distribution: US Nationwide distribution in the states of NJ, WI.
Product codes and lots: (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2635-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2635-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-25

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)