Z-1282-2024 Class II
FDA device recall Z-1282-2024 was initiated by Fresenius Kabi USA, LLC on Sep 16, 2022 and is designated Class II. Reason for recall: 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… Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Sep 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of WI and NJ.
Code Information
UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1282-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026