Sonendo recalls GentleWave Posterior CleanFlow Procedure Instrument with Matrices (REF GW-PST-PI01) due to erroneous unit carton labels. No action needed as labels don't affect safety.
Procedure Instruments with erroneous unit carton labels.
Sonendo is recalling a specific GentleWave Posterior CleanFlow Procedure Instrument with Mat: REF GW-PST-PI01. The recall is for erroneous carton labels, which do not pose a safety risk. No action is required as the labels don't affect the instrument's function or safety.
The recall addresses incorrect carton labels on the instrument. These labels do not cause safety hazards or affect the instrument's performance. The issue is purely labeling-related and not a functional defect.
Healthcare professionals using the GentleWave Posterior CleanFlow Procedure Instrument with Matrices (REF GW-PST-PI01) are likely affected. The risk is minimal as the labels do not impact safety or function.
Check for the model reference GW-PST-PI01 on the carton. The instrument was sold with lot number W2022080204R. Labels may be incorrect but do not impact safety.
Verify the carton label matches the model reference GW-PST-PI01 and lot number W2022080204R.
No action is needed as the erroneous labels do not pose a safety risk.
The recall is for labeling issues only, which do not affect safety or instrument function.
Look for the model reference GW-PST-PI01 and lot number W2022080204R on the carton.
We’ve drafted a message you can send Sonendo to request your refund or repair — edit it as you like.
Subject: Recall Z-0234-2023 — Sonendo Sonendo Hello, I own a Sonendo that is covered by recall Z-0234-2023 from Sonendo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
