Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: 3/11/2024
Class II
PRODUCT
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Recall Number:
Z-1282-2024
REASON:
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
RECALLING FIRM/MANUFACTURER:
Fresenius Kabi USA, LLC
VOLUME OF PRODUCT IN COMMERCE:
3
DISTRIBUTION:
US Nationwide distribution in the states of WI and NJ.
