medical Class II Updated 2024-11-06

Nihon Kohden America Inc recalls Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor

Recalled Product

Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box


Hazard / Issue

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

Issued by

FDA

Affected States: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, WI
Lot/Code Info: Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
View official government recall

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