GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Company
- Sonendo Inc
- Recall Initiated
- October 14, 2022
- Posted
- November 14, 2022
- Recall Number
- Z-0234-2023
- Quantity
- 16 instruments
- Firm Location
- Laguna Hills, CA
Reason for Recall
Procedure Instruments with erroneous unit carton labels.
Distribution
Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Lot / Code Info
GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R
Root Cause
Under Investigation by firm
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