Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System sterilization trays due to incorrect drying time in the operators 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 operators manual states a 30-minute drying cycle when 40 minutes is required for complete drying. This could lead to incomplete sterilization of surgical tools.
The sterilization tray requires 40 minutes for complete drying, but the operators manual states 30 minutes. This mismatch could result in surgical tools not being properly sterilized, potentially causing infections.
Healthcare professionals using the C7000 Clarity system with the specified sterilization tray model are affected. Those handling surgical tools after incomplete sterilization are at higher risk.
Check for the model number C7136 Rev C or 72904491 Rev A on the sterilization tray. The system was sold with the Czech OPS Manual and part number 60905787.
Verify the model number on the tray is C7136 Rev C or 72904491 Rev A.
The operators manual states a 30-minute drying cycle for the sterilization tray, but 40 minutes is required for complete drying, risking incomplete sterilization.
The recall record does not specify a remedy, so contact Integra LifeSciences for guidance.
This could lead to incomplete sterilization of surgical tools, potentially causing infections, but the recall record does not specify immediate action.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0651-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0651-2020 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.
