Z-0267-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67
Product Description
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Reason for Recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Distribution Pattern
U.S.: 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, and WI. O.U.S.: N/A
Code Information
Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers