Baxter Novum IQ Large Volume Pump — Class I medical device recall Z-2173-2025
Ongoing recall by Baxter Healthcare Corporation, reported 2025-08-20, distributed nationwide. Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the pote
| Recall number | Z-2173-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2025-07-14 |
| Classified | 2025-08-14 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 36,705 units |
| UPC / GTIN / UDI-DI | 05413765851797 |
| Model numbers | 40700BAXUS |
Product
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Reason for recall
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2173-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.