Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxyge
Summary
The FDA issued a Class II for Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to samp by Nihon Kohden America Inc. Reason: Due to products being shipped/distributed to customers after the products expiration date had past..
Details
Source
Device Recall
External ID
Z-0314-2025
Action Date
2024-11-13
Status
Ongoing
Category
device
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.
Lot/Code Info: Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
Quantity Affected: 17 devices
Reason for Recall
Due to products being shipped/distributed to customers after the products expiration date had past.
Distribution
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-29
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nihon Kohden America Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nihon Kohden America Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nihon Kohden America Inc have FDA actions?
Nihon Kohden America Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0314-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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