Recall Z-3153-2024— Fresenius Kabi USA, LLC
Class I · Ongoing
Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2024-08-30. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.. Reason: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death..
- Recalling firm
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-08-30
- Firm location
- North Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reason for recall
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Data sourced from openFDA. This site is unofficial and independent of the FDA.