Z-1964-2025 Class II Ongoing
FDA device recall Z-1964-2025 was initiated by Baxter Healthcare Corporation on May 12, 2025 and is designated Class II. Reason for recall: Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on… The recall status is ongoing. Affected quantity: 8027 units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 18, 2025
- Initiation Date
- May 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8027 units
Product description
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Reason for recall
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
Distribution pattern
US Nationwide distribution.
Code information
UDI/DI 05413765852428, All Serial Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1964-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026