Z-2096-2025 Class I Ongoing
FDA device recall Z-2096-2025 was initiated by Baxter Healthcare Corporation on June 20, 2025 and is designated Class I. Reason for recall: Certain Spectrum infusion pumps may have an incorrect version of software. The recall status is ongoing. Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2025
- Initiation Date
- June 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Reason for Recall
Certain Spectrum infusion pumps may have an incorrect version of software.
Distribution Pattern
US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Code Information
UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201