FDA Device recall Z-2173-2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
- FDA Device
- Class I
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class I recall of Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS by Baxter Healthcare, citing 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 high….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2173-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-14 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Reason
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.
Identifiers
| code_info | UDI/DI 05413765851797, All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.