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.
Reported: November 13, 2024 Initiated: April 29, 2022 #Z-0314-2025
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.
Details
- Recalling Firm
- Nihon Kohden America Inc
- Units Affected
- 17 devices
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nihon Kohden America Inc. Units affected: 17 devices.
Why was this product recalled? ▼
Due to products being shipped/distributed to customers after the products expiration date had past.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0314-2025.
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