Z-2415-2025 Class II Ongoing
FDA device recall Z-2415-2025 was initiated by Baxter Healthcare Corporation on Jul 14, 2025 and is designated Class II. Reason for recall: Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the… The recall status is ongoing. Affected quantity: 6 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 3, 2025
- Initiation Date
- Jul 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product description
Spectrum IQ Infusion Pump, Product Code 3570009
Reason for recall
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Distribution pattern
US distribution to states of: AZ, FL
Code information
UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2415-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026