Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System sterilization trays that may not dry fully after 30-minute cycles, risking infection. Affected units have specific model numbers and were sold with Chinese-Traditional OPS manuals.
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 meet the required drying time for 30-minute cycles. This could lead to incomplete sterilization and infection risks if the tray isn't dried properly.
The sterilization tray requires 40 minutes for complete drying but the system's manual states 30 minutes. If the tray isn't dried long enough, it may not sterilize properly, increasing infection risk during medical procedures.
Healthcare professionals using the C7000 Clarity system with the specified sterilization tray model numbers are most at risk. Patients using the system may face infection risks if the tray isn't properly sterilized.
Check for model numbers C7136 Rev C or 72904491 Rev A on the sterilization tray. The system was sold with Chinese-Traditional OPS manuals and part number 60905205.
Look for model numbers C7136 Rev C or 72904491 Rev A on the tray.
The sterilization tray does not meet the required drying time for a 30-minute cycle, which could lead to incomplete sterilization and infection risks.
The affected model numbers are C7136 Rev C and 72904491 Rev A.
Check for model numbers C7136 Rev C or 72904491 Rev A on the sterilization tray. The system was sold with Chinese-Traditional OPS manuals and part number 60905205.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0632-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0632-2020 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.
