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.
This recall is currently active, issued November 6, 2024. It was issued by Nihon Kohden America Inc.
- Company
- Nihon Kohden America Inc
- Recall Initiated
- April 29, 2022
- Posted
- November 6, 2024
- Recall Number
- Z-0314-2025
- Quantity
- 17 devices
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
Root Cause
Process control
Action Taken
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 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 VitalSignsTechSupport@nihonkohden.com.