Integra 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 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 dry properly, leading to incomplete sterilization and potential infection risks.
Medical professionals using the C7000 Clarity system with the specific sterilization tray model are most at risk. Patients using the device may face infection risks if the sterilization process is compromised.
Check for the C7136 Rev C or 72904491 Rev A sterilization tray model numbers on the device. The system was sold with Chinese-Simplified OPS manual P/N 60905206.
Identify if your device has the C7136 Rev C or 72904491 Rev A sterilization tray model numbers.
The 36 kHz Sterilization Tray does not meet the required 40-minute dry time for complete sterilization, but the system's manual states 30 minutes.
The official recall notice does not specify a remedy or action steps for affected devices.
The recall indicates a risk of incomplete sterilization, which could lead to infection, but no specific injury mechanism is described.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0634-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0634-2020 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.
