Integra C7000 CUSA Clarity System Recalled for Sterilization Drying Defect
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz sterilization tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a discrepancy in drying time instructions which could impact sterilization efficacy, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system. The product was distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong.
The recall was initiated because the 36 kHz Sterilization Tray system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states that 30 minutes is the minimum Dry Time for the 36 kHz Sterilization Tray and components. However, 40 minutes is required for complete drying. This discrepancy means the equipment may not be fully dry when the manual indicates the cycle is complete.
Healthcare facilities and users of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System should stop using the affected 36 kHz Sterilization Tray system and contact Integra LifeSciences Corp. for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 820
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Chinese-Traditional OPS Manual P/N 60905777
Distribution
Part of a larger recall action
This product is one of 42 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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