Z-0314-2025 Class II Ongoing
FDA device recall Z-0314-2025 was initiated by Nihon Kohden America Inc on April 29, 2022 and is designated Class II. Reason for recall: Due to products being shipped/distributed to customers after the products expiration date had past. The recall status is ongoing. Affected quantity: 17 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- April 29, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 devices
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.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Code Information
Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB