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.
Reported: October 4, 2023 Initiated: April 22, 2022 #Z-2635-2023
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
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 1344 pumps
- Distribution
- US Nationwide distribution in the states of NJ, WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 1344 pumps.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2635-2023.
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