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.
Check against the official notice below — it lists the full affected range.
Fresenius Kabi USA, LLC is recalling 1,344 Ivenix Infusion System Large Volume Pumps with software versions 5.0.0 and 5.0.1 that were distributed nationwide, with specific distribution in New Jersey and Wisconsin. The pumps are used in hospitals and outpatient care settings to deliver intravenous fluids and medications. The recall addresses a hazard where the start-up time for flow rates between 50 and 200 milliliters per hour may exceed the specified 6-minute limit, depending on how air bubbles become trapped within the administration set's Intermediate Pumping Chamber.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: US Nationwide distribution in the states of NJ, WI. Quantity: 1344 pumps Lot/code info: (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.