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Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Recalled December 18, 2019 · FDA recall Z-0633-2020 · Integra LifeSciences
Hazard
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. · FDA Class II
Units
820
Sold at
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Description
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.
Product
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →