Medical Device Recall: 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
Nihon Kohden America Inc · April 29, 2022
Reason for Recall
Due to products being shipped/distributed to customers after the products expiration date had past.
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.
Distribution
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
States Affected
NATIONWIDE
Quantity Affected
17 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0314-2025
Status: ongoing
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