Z-0002-2023 Class I Terminated
FDA device recall Z-0002-2023 was initiated by Fresenius Kabi USA, LLC on Sep 8, 2022 and is designated Class I. Reason for recall: The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen… The recall status is terminated (terminated Sep 10, 2024). Affected quantity: 4 instances.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2022
- Initiation Date
- Sep 8, 2022
- Termination Date
- Sep 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 instances
Product Description
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Reason for Recall
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Distribution Pattern
Domestic distribution to NJ and WI.
Code Information
UDI-DI: 00811505030122 version 5.2.0
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0002-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026