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Recall

Class I — Baxter Healthcare Corporation

Recalling firmBAXTER HEALTHCARE CORPORATION
Registered facilityView this company's 32 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusOngoing
ReasonThere 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.
ProductBaxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Quantity34,524 units
DistributionUS and Canada
Initiated2025-04-24
Classified2025-05-20
Recall numberZ-1767-2025
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class I recall — Baxter Healthcare Corporation (Z-1767-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96721/

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