Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System due to 36 kHz sterilization tray not meeting required drying time for 30-minute cycles, 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 (C7136 Rev C / 72904491 Rev A) because it doesn't dry properly for 30-minute cycles as required. This could lead to incomplete sterilization of surgical tools, potentially causing infections during procedures.
The sterilization tray requires 40 minutes for complete drying but the system only allows 30 minutes. This means surgical tools may not be fully sterilized after each cycle, increasing infection risk during procedures.
Healthcare professionals using the C7000 Clarity system with the specific sterilization tray model are most at risk. Patients undergoing surgery with improperly sterilized tools could face infection risks.
Check for the model number C7136 Rev C or 72904491 Rev A on the sterilization tray. The system was sold with the C7000 Clarity Ultrasonic Tissue Ablation System and OUS Ops Manual P/N 60905217.
Look for model numbers C7136 Rev C or 72904491 Rev A on the tray.
The 36 kHz Sterilization Tray does not meet the required 40-minute drying time for complete sterilization, but the system's manual states 30 minutes.
The recall record does not specify a remedy or action steps for affected users.
The hazard involves potential incomplete sterilization, which could lead to infection risks during surgery, but the recall record does not specify immediate danger.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0616-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0616-2020 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.
