Recall Z-0763-2025— Fresenius Kabi USA, LLC
Class I · Ongoing
Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2024-12-06. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004. Reason: Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used..
- Recalling firm
- Fresenius Kabi USA, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-12-06
- 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, Model Number: LVP-0004
Reason for recall
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.