Recall Z-0314-2025 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Nihon Kohden America Inc
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.
| Date | Nov 6, 2024 (initiated Apr 29, 2022) |
| Status | Open, Classified |
| Reason | Due to products being shipped/distributed to customers after the products expiration date had past. |
| Root cause | Process control |
| Action | On 05/02/2022, the firm emailed an "URGENT NOTIFICATION" to customers informing them that the YG-227T adult cap-ONE Biteblock were shipped/distributed past their labeled expiration date. Customers were instructed to: 01.Identify any YG-227T packages you have in inventory 02.Complete the attached Medical Device Notification Return Response Form 03.Email the completed Medical Device Notification Return Response Form back to NKA Technical Servicesat VitalSignsTechSupport@nihonkohden.com. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and will either be exchanged for new |
| Quantity | 17 devices |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171765 | Nihon Kohden CO2 Monitor Nihon Kohden Corporation, Oct 11, 2017 |