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 could lead to incomplete sterilization, increasing the risk of infection if the device is used without proper drying.
Healthcare professionals using the C7000 Clarity system in Brazil. Those handling the sterilization trays without verifying the drying time are most at risk.
Check for the C7136 Rev C or 72904491 Rev A sterilization tray model numbers on the C7000 Clarity system. The device was sold in Brazil with the Brazilian OPS manual.
Check the sterilization tray model number to confirm it's C7136 Rev C or 72904491 Rev A.
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.
Check the sterilization tray model number to see if it's affected. If it is, verify the drying time with the manufacturer.
The official recall record does not mention a remedy or fix.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0637-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0637-2020 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.
