Z-2635-2023 Class II Ongoing
FDA device recall Z-2635-2023 was initiated by Fresenius Kabi USA, LLC on Apr 22, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1344 pumps.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 4, 2023
- Initiation Date
- Apr 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1344 pumps
Product Description
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.
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
Distribution Pattern
US Nationwide distribution in the states of NJ, WI.
Code Information
(UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2635-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026