Z-0151-2024 Class I Ongoing
FDA device recall Z-0151-2024 was initiated by Baxter Healthcare Corporation on Oct 13, 2023 and is designated Class I. Reason for recall: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete… The recall status is ongoing. Affected quantity: 2023 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 15, 2023
- Initiation Date
- Oct 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2023 units
Product description
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Reason for recall
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
Distribution pattern
US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Code information
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-0151-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026