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U.S. Department of Health and Human Services

Class 2 Device Recall Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m

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 Class 2 Device Recall Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9msee related information
Date Initiated by FirmSeptember 18, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0267-2025
Recall Event ID 95426
Product Classification Oximeter - Product Code DQA
ProductNihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Code Information Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
FEI Number 2080783
Recalling Firm/
Manufacturer		 Nihon Kohden America Inc
15353 Barranca Pkwy
Irvine CA 92618-2216
For Additional Information ContactSandra Gadeyne
800-325-0283
Manufacturer Reason
for Recall		Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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.
Quantity in Commerce67
DistributionU.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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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