Official recall notice

FDA DeviceClass IINotable

FDA Recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Recall date
2026-06-10
FDA class
Class II

Why it was recalled

Hazard

Potential for the Cassette Loading Lever to break.

Recommended action

What to do

18,444 installed bases

Product description

Potential for the Cassette Loading Lever to break.

Verify with the official notice →
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