Company: Fresenius Kabi USA
Date of Enforcement Report: 12/05/2024
PRODUCT
The Ivenix LVP is a large volume infusion pump designed to deliver fluids and medications from one of two inlet source containers to the patient through a single outlet. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient.
- UDI 00811505030320
REASON:
Fresenius Kabi USA reports that a subset of pneumatic valves installed in some Ivenix LVPs have an increased chance of issuing a non-recoverable pump problem alarm. All devices with the affected valves, should be removed from use, as described in the What to do section above, to be evaluated and returned to Fresenius Kabi’s facility for repair.
RECALLING FIRM/MANUFACTURER:
Fresenius Kabi USA
DISTRIBUTION:
United States
