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FDA (Device enforcement)Recalled 2025-06-20class i

Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

Hazard

Certain Spectrum infusion pumps may have an incorrect version of software.

Details from the source

Reason for recall: Certain Spectrum infusion pumps may have an incorrect version of software. Distribution: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA. Quantity: 28 units Lot/code info: 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

UPC codes

00085412498683

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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