Integra LifeSciences recalls C7000 Clarity Ultrasonic Tissue Ablation System sterilization trays due to incorrect drying time in the operator's manual, 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 (C7136 Rev C / 72904491 Rev A) because the operator's manual states a 30-minute drying cycle when 40 minutes is required for complete drying. This could lead to incomplete sterilization of surgical instruments.
The sterilization tray requires 40 minutes for complete drying to ensure proper sterilization, but the operator's manual states 30 minutes. This discrepancy could lead to incomplete sterilization of surgical instruments, potentially causing infections.
Medical professionals using the C7000 Clarity system with the specified sterilization tray model are most at risk. Patients using the system may face infection risks if instruments are not properly sterilized.
Check for the sterilization tray model C7136 Rev C or 72904491 Rev A with the C7000 Clarity Ultrasonic Tissue Ablation System. The product was sold with the Polish OPS Manual P/N 60905213.
Identify the model number on the sterilization tray (C7136 Rev C or 72904491 Rev A) to confirm if it is affected.
The operator's manual states a 30-minute drying cycle for the tray, but 40 minutes is required for complete drying to ensure proper sterilization.
The recall record does not specify a remedy, so contact Integra LifeSciences for guidance.
The recall record indicates a potential risk of incomplete sterilization, which could lead to infections if surgical instruments are not properly sterilized.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0648-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0648-2020 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.
