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.
Recall
- Recall Number
- Z-0314-2025
- Event Number
- 95480
- Firm
- Nihon Kohden America Inc
- FEI Number
- 2080783
- Product Code
- CCK
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 29, 2022
- Posted
- November 6, 2024
- Address
- 15353 Barranca Pkwy, Irvine, CA, 92618-2216
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.
Due to products being shipped/distributed to customers after the products expiration date had past.
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 [email protected]. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and will either be exchanged for new YG-227T or a full refund will be issued for unused product. If you have questions about this notification or the form below, please call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email [email protected].
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
17 devices