Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error
Integra LifeSciences is recalling the C7000 CUSA Clarity system because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.
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 is a documentation error regarding drying time, which is a minor labeling/instruction issue without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
Integra LifeSciences Corp. is recalling the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is due to a documentation error in the CUSA Clarity Operators manual regarding the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A).
The manual currently states that the minimum dry time for the 36 kHz Sterilization Tray and components is 30 minutes. However, the system does not meet the Dry Time Criteria for a 30-minute cycle, and 40 minutes is required for complete drying. This discrepancy means the provided instructions do not ensure the equipment is fully dried.
The affected product was distributed in the United States and internationally. Users of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System should refer to the updated instructions or contact the manufacturer for guidance on the correct drying time.
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)
- Dutch OPS Manual P/N 60905783
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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