GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
FDA device recall Z-0234-2023 · posted 2022-11-14 · Open, Classified
Recall details
- Recalling firm
- Sonendo Inc
- Reason for recall
- Procedure Instruments with erroneous unit carton labels.
- Action taken
- On 10/14/2022, the firm sent an "URGENT PRODUCT ADVISORY NOTICE" Letter via FedEx to customers informing them that there are error in the external labeling on the product carton. Information missing includes: a) The GentleWave brand identification; b) The Sonendo brand identification; c) Information such as: "Manufactured by:" and various ISO informational labeling symbols Customers are instructed: -Complete and return (fax or email) the Customer Acknowledgement Letter. -No other action are required. The product and the labeling on the product pouches inside the cartons is correct and unaffected by this error. The labeling has sufficient information to ensure that all customer can correctly identify different Procedure Instruments prior to use. This Notice is intended to reduce any possible confusion to the customer due to the labeling error. For questions, contact Sonendo Customer Support between 7:00 a.m. to 4:00 p.m. (PST) at 1-844-468-5928 or via email to complaints@sonendo.com
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- ELC
- Quantity affected
- 16 instruments
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
- Date initiated
- 2022-10-14
- Date posted
- 2022-11-14
- Location
- Laguna Hills, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sonendo GentleWave System (K190359) | Sonendo, Inc. | 2019-03-16 |