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Recall Observatory FDA recall evidence

Device product

Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

Z-1767-2025

April 24, 2025

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 96721
Status
Ongoing
Classification
Class I
Quantity
34,524 units
Official record key
device-enforcement:Z-1767-2025

Official wording

Reason: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.

Code information: All serial numbers

Distribution pattern: US and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.