FDAFDA · Food and drugs·Recall number Z-0314-2025
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.
Published November 13, 2024 · Recall initiated: April 29, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to products being shipped/distributed to customers after the products expiration date had past.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nihon Kohden America Inc
- Distributor
- U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
- Lot
- Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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