Integra recalls C7000 Clarity Ultrasonic Tissue Ablation System due to 30-minute drying cycle not meeting required 40-minute dry time for sterilization trays, risking incomplete sterilization.
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.
Integra is recalling the C7000 Clarity Ultrasonic Tissue Ablation System because its sterilization tray doesn't dry long enough for proper sterilization. This could lead to incomplete sterilization and potential infection risks if the device is used without proper drying.
The sterilization tray requires 40 minutes to fully dry after use, but the system is set to 30 minutes. This incomplete drying could lead to inadequate sterilization, potentially causing infections during medical procedures.
Medical professionals using the C7000 Clarity system with the specific sterilization tray model (C7136 Rev C / 72904491 Rev A) are most at risk. Patients receiving procedures with this device may also be affected.
Check for the C7136 Rev C or 72904491 Rev A model numbers on the sterilization tray. The system was sold with the Norwegian OPS Manual and part number 60905216.
Look for the model number C7136 Rev C or 72904491 Rev A on the sterilization tray.
The 36 kHz Sterilization Tray does not meet the required 40-minute dry time for complete sterilization, but the system is set to 30 minutes.
The recall record does not specify a remedy, so no action is required beyond checking the model number.
The recall indicates incomplete sterilization could lead to infection risks, but the official notice does not specify the likelihood or severity.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0654-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0654-2020 from Integra LifeSciences. 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.
