Z-1484-2024 Class I Ongoing
FDA device recall Z-1484-2024 was initiated by Fresenius Kabi USA, LLC on Mar 7, 2024 and is designated Class I. Reason for recall: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. The recall status is ongoing. Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2024
- Initiation Date
- Mar 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Reason for Recall
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Distribution Pattern
US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Code Information
Product LVP-SW-0004; UDI-DI 00811505030122.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1484-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026