FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Recall number
- Z-0848-2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Status
- Open, Classified
- Initiated
- 2025-11-03
- Posted
- 2025-12-01
- Terminated
- not on file
- Reason
- Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- Root cause
- Labeling design
- Action
- Fresenius Kabi notified consignees on about 11/03/2025 via emailed letter. Consignees were informed of the issue and instructed to account for additional backpressure if check valve is used when configuring the downstream occlusion pressure alarm setting, adjust the occlusion alarm pressure to allow for a more balanced approach between occlusion detection and avoidance of unnecessary alarms, and continue to follow all Instructions for Use and institutional policies regarding infusion pump setup, monitoring, and alarm response. Consignees were requested to ensure all relevant persons within the organization are informed about this letter and the actions as described per the enclosed Tip Sheet on How to Use a Check Valve with the Ivenix Pump & Administration Sets. Additionally, consignees were requested complete and return the Customer Reply Form. Fresenius Kabi plans to update the Instructions for Use to include the information presented in the "Required Actions for Users", "Important Note on Check Valve Usage" and/or Tip Sheet on "How to Use a Check Valve with the Ivenix Pump & Administration Sets" for which scheduling is still being finalized.
- Quantity
- 15,862 units
- Distribution
- US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
- Lot, serial or model codes
- Model Number: LVP-0004. UDI-DI: 00811505030320.
- 510(k) numbers
- ["K183311"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3014732157
- Firm city
- North Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28