Adult 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.
FDA Recall Z-0314-2025 · Posted 2024-11-06
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Recalling FirmNihon Kohden America Inc
Recall StatusOpen, Classified
Product CodeCCK
Date Initiated2022-04-29
Product Quantity17 devices
Reason for Recall
Due to products being shipped/distributed to customers after the products expiration date had past.
Firm Action
On 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 [email protected].
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 [email protected].
Root Cause
Process control
Distribution Pattern
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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