Nihon Kohden America Inc recalls Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxyge

Recalled November 13, 2024 · FDA recall Z-0314-2025 · Nihon Kohden America

Hazard

Due to products being shipped/distributed to customers after the products expiration date had past. · FDA Class II

Units

17 devices

Sold at

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

Description

Due to products being shipped/distributed to customers after the products expiration date had past.

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.

Manufacturer(s)

Nihon Kohden America Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →