Recall Z-2274-2026 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
| Date | May 29, 2026 (initiated Feb 4, 2026) |
| Status | Open, Classified |
| Reason | Potential for the Cassette Loading Lever to break. |
| Root cause | Device Design |
| Action | Fresenius Kabi notified consignees on about 02/04/2026 via letter. Consignees were informed of the lever breakage and that two potential sources of the breakage were: 1. If the Cassette Loading Lever is left open during transport, it can be damaged if it is jarred by another object or surface. 2. Applying force to a locked Loading Lever when it is in the locked position can result in potential damage and/or cause it to break. Consignees were reminded of proper Loading Lever handling: 1. Do not force the Cassette Loading Lever open or closed. The lever does not require significant force to |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |