Recall Z-0268-2025
Nihon Kohden America Inc · initiated September 18, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Codes / lots: Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
Reason for recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
FDA-determined cause: No Marketing Application
Action taken
On 10/07/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" via certified mail or FedEx informing customers that the Sp02 sensor's intended use was not reviewed/evaluated by the FDA and does not have market approval or clearance for distribution in the U.S. Customers are instructed to: 1. Identify any Caremed SpO2 sensor packages you have in inventory and cease use of the affected product. 2. Complete the attached Medical Device Notification Return Response Form 3. Email the completed Medical Device Notification Return Response Form back to NKA Technical Services at vitalsignsTS@nihonkohden.com. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and a full refund will be issued for unused product. Please contact Nihon Kohden Technical Support to coordinate the return of the affected product. If you have questions about this notification or the form below, please call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email vitalsignsTS@nihonkohden.com.
Details
- Recall number
- Z-0268-2025
- Initiated
- September 18, 2024
- Posted by FDA
- October 30, 2024
- Product code
- DQA – Oximeter
- Quantity
- 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
- Recalling firm
- Nihon Kohden America Inc, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0267-2025 Class II | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp.…Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | 09/18/2024Open, Classified |