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 (model C7136 Rev C / 72904491 Rev A) because it doesn't dry properly in 30-minute cycles as required. This could lead to incomplete sterilization, potentially causing infections or contamination 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 the risk of contamination or infection during medical procedures.
Healthcare professionals using the C7000 Clarity system with the specific sterilization tray model are affected. Patients undergoing procedures with this equipment could be at risk 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 Portuguese language operator manuals.
Identify the model number on the tray (C7136 Rev C or 72904491 Rev A) to confirm if it's affected.
The tray does not meet the required drying time for a 30-minute cycle, which could lead to incomplete sterilization.
The recall record does not specify a remedy, so contact Integra LifeSciences for guidance.
The recall focuses on potential contamination risks, not direct injury. The hazard is low risk as it relates to sterilization effectiveness.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0635-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0635-2020 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.
