Recall Z-0314-2025— Nihon Kohden America Inc
Class II · Ongoing
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2022-04-29. It names one FDA 510(k) clearance: K171765. Product: 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.. Reason: Due to products being shipped/distributed to customers after the products expiration date had past..
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-29
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Due to products being shipped/distributed to customers after the products expiration date had past.
Data sourced from openFDA. This site is unofficial and independent of the FDA.