Integra C7000 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 discrepancy in drying time documentation and performance, which is a moderate risk of improper sterilization but does not involve reported injuries or high-risk pathogens.
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) and the Danish OPS Manual (P/N 60905781). The product was distributed in the United States and internationally.
The recall was initiated because the 36 kHz Sterilization Tray system does not meet the Dry Time Criteria for a 30-minute drying cycle. While the current CUSA Clarity Operators manual states that 30 minutes is the minimum Dry Time for the 36 kHz Sterilization Tray and components, 40 minutes is actually required for complete drying.
Healthcare facilities and users of the C7000 CUSA Clarity System should contact Integra LifeSciences Corp. for further instructions regarding the recall and potential corrective actions.
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)
- Danish OPS Manual P/N 60905781
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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