The Large Volume Pump recall
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Why was The Large Volume Pump recalled?
Potential for the Cassette Loading Lever to break.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: LVP-0004. UDI-DI: 00811505030320
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 18,444 installed bases
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Recall date
- June 10, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)