Nihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device distributed without FDA market approval or clearance. While no specific defects, injuries, or illnesses are reported in the source, the regulatory violation represents a risk-of-harm situation in critical patient monitoring applications where safety and effectiveness have not been established.
Plain-English summary
Nihon Kohden America is recalling the Adult/Pediatric Forehead Disposable SpO2 Sensor, Model 809030006. This device is used in clinical settings to measure blood oxygen saturation in patients. Approximately 67 units were distributed to healthcare facilities across the United States.
The recall was issued because the device was distributed in the United States without FDA market approval or clearance. Without proper FDA clearance, the device has not been reviewed by the FDA to ensure its safety and effectiveness.
If your healthcare facility or clinic has received this device, discontinue use immediately and contact Nihon Kohden America Inc for instructions on returning or disposing of the recalled units. Patients who were treated with this device should contact their healthcare provider.
The recalled product
- Product
- Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
- Manufacturer
- Nihon Kohden America Inc
- Hazard
- Affected units
- 67
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nihon Kohden America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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