Integra C7000 CUSA Clarity System Recalled for Inadequate Drying Time
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria 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 documentation error regarding drying time, which is a low-risk contamination or labeling issue without reported injuries, fitting the Moderate severity criteria.
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 associated Norwegian OPS Manual (P/N 60905216).
The recall is due to a discrepancy in the drying time requirements. 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, as 40 minutes is required for complete drying.
The affected products were distributed in the United States and internationally. Users should refer to the recall notice for specific instructions on how to proceed.
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)
- Norwegian OPS Manual P/N 60905216
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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