Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen,
FDA device recall Z-0314-2025 · posted 2024-11-06 · Open, Classified
Recall details
- Recalling firm
- Nihon Kohden America Inc
- Reason for recall
- Due to products being shipped/distributed to customers after the products expiration date had past.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- CCK
- Quantity affected
- 17 devices
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
- Date initiated
- 2022-04-29
- Date posted
- 2024-11-06
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Nihon Kohden CO2 Monitor (K171765) | Nihon Kohden Corporation | 2017-10-11 |