Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System due to 30-minute drying cycle not meeting required 40-minute dry time for sterilization trays, 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 because the sterilization tray doesn't dry long enough for proper sterilization. This could lead to incomplete sterilization of surgical tools, potentially causing infections during procedures.
The sterilization tray requires 40 minutes for complete drying but the system only allows 30 minutes. This means surgical tools may not be properly sterilized, increasing infection risk during procedures.
Healthcare professionals using the C7000 Clarity system for surgical procedures are most at risk if the sterilization tray isn't dried long enough.
Check for the C7136 Rev C or 72904491 Rev A sterilization tray model numbers on the C7000 Clarity system. The system was sold with the Swedish OPS manual and part number 60905774.
Identify the model number on the sterilization 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 dry time for a 30-minute drying cycle, which could lead to incomplete sterilization of surgical tools.
Incomplete sterilization of surgical tools could increase infection risk during procedures.
Check for the C7136 Rev C or 72904491 Rev A sterilization tray model numbers on the C7000 Clarity system with the Swedish OPS manual and part number 60905774.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0625-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0625-2020 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.
