Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Reported: November 6, 2024 Initiated: September 18, 2024 #Z-0268-2025
Product Description
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Reason for Recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Details
- Recalling Firm
- Nihon Kohden America Inc
- Units Affected
- 64
- 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
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each. Recalled by Nihon Kohden America Inc. Units affected: 64.
Why was this product recalled? ▼
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0268-2025.
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