Baxter Healthcare Corporation medical device recall: Baxter Novum IQ LVP INFUSION SYSTEM
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96721
- Recall initiated
- Apr 24, 2025
- Classified by FDA
- May 20, 2025
- Posted in Enforcement Report
- May 28, 2025
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 24, 2025. FDA classified it 26 days later, on May 20, 2025. Distribution reported by FDA: US and Canada Baxter Healthcare Corporation has 279 recalls in our records.
Recalled products (1)
Z-1767-2025 Class I Ongoing
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Codes / lots: All serial numbers
Quantity: 34,524 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 96721
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.