Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System sterilization trays due to incorrect drying time in the 30-minute cycle, 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 LifeSciences is recalling the C7000 Clarity Ultrasonic Tissue Ablation System's 36 kHz Sterilization Tray (model C7136 Rev C / 72904491 Rev A) because it doesn't meet the required 40-minute drying time for complete sterilization. This could lead to incomplete sterilization and potential infection risks if the system is used without proper drying.
The sterilization tray requires 40 minutes for complete drying to ensure proper sterilization. The current system only allows 30 minutes, which may result in incomplete sterilization and potential infection risks.
Healthcare professionals using the C7000 Clarity system with the specific sterilization tray model are most at risk. Patients using the system may face infection risks if the tray isn't properly sterilized.
Check for the model number C7136 Rev C or 72904491 Rev A on the sterilization tray. The system was sold with the Dutch OPS Manual and part number 60905211.
Verify the model number on the tray is C7136 Rev C or 72904491 Rev A.
The 36 kHz Sterilization Tray does not meet the required 40-minute drying time for complete sterilization, as the current manual states 30 minutes instead of 40 minutes.
The recall record does not specify a remedy, so check with Integra LifeSciences for guidance.
The recall indicates incomplete sterilization could lead to infection risks if the tray isn't properly dried.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0644-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0644-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
