Device product
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Z-2274-2026
Product summary
- Event
- Event 98699
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,444 installed bases
- Official record key
device-enforcement:Z-2274-2026
Official wording
Reason: Potential for the Cassette Loading Lever to break.
Code information: Model Number: LVP-0004. UDI-DI: 00811505030320
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for the Cassette Loading Lever to break.