GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
FDA Recall Z-0234-2023 · Posted 2022-11-14
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Recalling FirmSonendo Inc
Recall StatusOpen, Classified
Product CodeELC
Date Initiated2022-10-14
Product Quantity16 instruments
Reason for Recall
Procedure Instruments with erroneous unit carton labels.
Firm Action
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 [email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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