Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System sterilization trays due to incorrect drying time in the operator manual, 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 the operator manual states a 30-minute drying cycle when 40 minutes is required for complete drying. This could lead to incomplete sterilization of surgical instruments.
The sterilization tray requires 40 minutes for complete drying, but the operator manual states 30 minutes. This mismatch could result in incomplete sterilization of surgical instruments, potentially leading to infections during procedures.
Surgical professionals using the C7000 Clarity system with the specific sterilization tray model are most at risk. The recall applies to devices sold with the Korean OPS manual and part number 60905212.
Check for the sterilization tray model C7136 Rev C or 72904491 Rev A with the Korean OPS manual and part number 60905212. The recall applies to the C7000 Clarity Ultrasonic Tissue Ablation System.
Identify the model number on the tray (C7136 Rev C or 72904491 Rev A) and confirm it matches the recalled version.
The operator manual states a 30-minute drying cycle for the tray, but 40 minutes is required for complete drying. This could lead to incomplete sterilization of surgical instruments.
The recall record does not specify a remedy or fix for this issue.
Check for the model number C7136 Rev C or 72904491 Rev A with the Korean OPS manual and part number 60905212.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0646-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0646-2020 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.
