Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
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 drying time discrepancy in a sterilization tray, which is a procedural defect rather than a direct structural failure or reported injury, fitting the Moderate severity criteria for low-risk contamination or procedural issues.
Plain-English summary
Integra LifeSciences Corp. is recalling the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system, which 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 36 kHz Components. However, the system requires 40 minutes for complete drying. This discrepancy means the equipment may not be fully dried within the timeframe specified in the provided documentation.
The affected products were distributed in the United States and internationally, including in Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. Healthcare facilities and users should stop using the affected sterilization trays and contact the manufacturer for further instructions.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
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)
- Korean OPS Manual P/N 60905212
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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