Nihon Kohden America Inc Recall 95426
Description: Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Nihon Kohden America Inc Recall 95426 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0268-2025 |
| Event ID | 95426 |
| Event Description | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 64 |
| Recall Reason | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| Device Classification | 20241106 |
| Device Code Info | Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers |
| Center Classification Date | 20241030 |
| Recall Initiation Date | 20240918 |
| Recalling Firm | Nihon Kohden America Inc |
| Initial Notification | Letter |
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