Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System's 36 kHz Sterilization Tray due to insufficient drying time for 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 meet the required 40-minute drying time for complete sterilization. This could lead to incomplete sterilization of surgical tools, potentially causing infections during procedures.
The sterilization tray requires 40 minutes for complete drying to ensure proper sterilization. However, the current system only allows a 30-minute drying cycle as per the operator's manual, which may lead to incomplete sterilization of surgical instruments.
Healthcare professionals using the C7000 Clarity system with the specified sterilization tray model are most at risk. Patients undergoing surgery with improperly sterilized instruments could face infection risks.
Check for the model number C7136 Rev C or 72904491 Rev A on the sterilization tray. The system was sold with Japanese operator's manuals (P/N 60905204).
Identify the model number on the tray (C7136 Rev C or 72904491 Rev A) to confirm if it's affected.
The 36 kHz Sterilization Tray does not meet the required 40-minute drying time for complete sterilization, as the current system only allows a 30-minute cycle.
The recall record does not specify a remedy or action for affected items.
The recall indicates a risk of incomplete sterilization, which could lead to infections, but the record does not specify how common this issue is or its severity in practice.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0630-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0630-2020 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.
