FDA-Device2024-11-13Class II
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.
Nihon Kohden America Inc
Hazard
Due to products being shipped/distributed to customers after the products expiration date had past.
Sold states
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Affected count
17 devices
Manufactured in
15353 Barranca Pkwy, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2025Don't want to check this manually?
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