Z-2334-2025 Class I Ongoing
FDA device recall Z-2334-2025 was initiated by Baxter Healthcare Corporation on August 4, 2025 and is designated Class I. Reason for recall: Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blan… The recall status is ongoing. Affected quantity: 22703 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- August 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22703 units
Product Description
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Reason for Recall
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Distribution Pattern
US distribution including Puerto Rico and OUS (International) Canada
Code Information
UDI/DI N/A, All Serial Numbers