Integra C7000 CUSA Clarity System Recalled for Inadequate Drying Time
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
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, which typically corresponds to a moderate severity. The issue is a procedural discrepancy regarding drying time rather than a direct structural failure or reported injury, fitting the criteria for a moderate risk.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is due to a defect in 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, 40 minutes is actually required for complete drying. This discrepancy means the equipment may not be properly dried according to the provided instructions.
The affected units were distributed in the United States and internationally. The specific code information associated with the recall is the Japanese OPS Manual P/N 60905776. Users of this equipment should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 820
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)
- Japanese OPS Manual P/N 60905776
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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