Recall Z-0549-2024— Fresenius Kabi USA, LLC
Class I · Ongoing
Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2023-11-29. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004. Reason: The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death..
- Recalling firm
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-11-29
- 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), Large Volume Pump LVP-0004
Reason for recall
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Data sourced from openFDA. This site is unofficial and independent of the FDA.