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 and potential infection risks if the device is used without proper drying.
The sterilization tray requires 40 minutes for complete drying but the system only allows 30 minutes. This means the tray may not be fully dry after use, increasing the risk of incomplete sterilization and potential infection.
Medical professionals using the C7000 Clarity system for surgical procedures are most at risk, particularly those who rely on the sterilization tray for tissue ablation.
Check for the C7000 Clarity Ultrasonic Tissue Ablation System with sterilization tray model C7136 Rev C or 72904491 Rev A. The system is identified by the US Ops Manual P/N 60905197.
Identify the model number on the sterilization tray (C7136 Rev C or 72904491 Rev A) to confirm if it is affected.
The system requires 40 minutes for complete drying, but the current cycle only allows 30 minutes, which may lead to incomplete sterilization.
The recall record does not specify a remedy, so contact Integra LifeSciences for guidance.
The recall indicates a risk of incomplete sterilization, which could lead to infection if the device is used without proper drying.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0614-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0614-2020 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.
