Reported Nov 13, 2024 · Ongoing
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen,…
Nihon Kohden America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nihon Kohden America Inc · 15353 Barranca Pkwy · Irvine, CA · 92618-2216
Is this the product you have?
- 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.
- Lot codes and dates
- ModelYG-227T
- DI14931921904043
- Lot Numbers
706121CB706301CB707211CB
- Amount recalled
- 17 devices
Where it was sold
Why it was recalled
Due to products being shipped/distributed to customers after the products expiration date had past.
This product could cause temporary or reversible health problems — stop using it.
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