Device 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.
Z-0314-2025
Product summary
- Event
- Event 95480
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17 devices
- Official record key
device-enforcement:Z-0314-2025
Official wording
Reason: Due to products being shipped/distributed to customers after the products expiration date had past.
Code information: Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
Distribution pattern: U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Derived failure modes
-
Unknown
Due to products being shipped/distributed to customers after the products expiration date had past.