GentleWave System Posterior CleanFlow Procedure recall
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Why was GentleWave System Posterior CleanFlow Procedure recalled?
Procedure Instruments with erroneous unit carton labels.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R
- Product
- GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Recalling firm
- Sonendo Inc
- Quantity
- 16 instruments
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
- Recall date
- November 23, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)