Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System's 36 kHz Sterilization Tray due to insufficient drying time in 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 because it doesn't dry properly in 30-minute cycles as required. This could lead to incomplete sterilization, potentially causing infections during medical procedures.
The sterilization tray requires 40 minutes for complete drying but the system's manual states 30 minutes. This mismatch means the tray may not dry fully, increasing infection risks during medical procedures.
Healthcare professionals using the C7000 Clarity system with the specific 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) are most at risk. Patients undergoing procedures with this equipment could face infection risks if sterilization is incomplete.
Check for the 36 kHz Sterilization Tray model C7136 Rev C or part number 72904491 Rev A. The system is part of the C7000 Clarity Ultrasonic Tissue Ablation System used in medical procedures.
Identify the tray model number on the device, which should be C7136 Rev C or part number 72904491 Rev A.
The 36 kHz Sterilization Tray does not meet the required drying time for a 30-minute cycle, which could lead to incomplete sterilization and infection risks.
The recall record does not specify a remedy, so contact Integra LifeSciences for guidance on next steps.
The recall indicates a risk of infection from incomplete sterilization, but no specific injury mechanism is described.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0647-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0647-2020 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.
