Integra C7000 CUSA Clarity System Recall for Sterilization Tray Drying Defect
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 labeling error regarding drying time, which is a procedural issue rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
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 60905209).
The recall is due to a discrepancy in the drying time requirements for the sterilization tray. The current CUSA Clarity Operators manual states that 30 minutes is the minimum dry time for the 36 kHz Sterilization Tray and components. However, the system does not meet the Dry Time Criteria for a 30-minute cycle, and 40 minutes is actually required for complete drying.
The affected products were distributed in the United States and internationally, including in Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. Users should verify the drying time requirements for their specific equipment and refer to the updated instructions provided by the manufacturer to ensure proper sterilization.
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 60905209
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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