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U.S. Department of Health and Human Services

Class 2 Device Recall Adult CapONE Biteblock

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 Class 2 Device Recall Adult CapONE Biteblocksee related information
Date Initiated by FirmApril 29, 2022
Date PostedNovember 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0314-2025
Recall Event ID 95480
510(K)NumberK171765 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductAdult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
Code Information Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
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 products being shipped/distributed to customers after the products expiration date had past.
FDA Determined
Cause 2		Process control
ActionOn 05/02/2022, the firm emailed an "URGENT NOTIFICATION" to customers informing them that the YG-227T adult cap-ONE Biteblock were shipped/distributed past their labeled expiration date. Customers were instructed to: 01.Identify any YG-227T packages you have in inventory 02.Complete the attached Medical Device Notification Return Response Form 03.Email the completed Medical Device Notification Return Response Form back to NKA Technical Servicesat VitalSignsTechSupport@nihonkohden.com. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and will either be exchanged for new YG-227T or a full refund will be issued for unused 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 VitalSignsTechSupport@nihonkohden.com.
DistributionU.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
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.
510(K) Database510(K)s with Product Code = CCK
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