FDA recall Z-0314-2025

Nihon Kohden America Inc · Class II · device

Product

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

U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.

Key facts

Status
Ongoing
Initiation date
2022-04-29
Report date
2024-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2025