Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual lists an incorrect minimum drying time for sterilization trays.
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: This is an FDA Class II recall involving a documentation error (incorrect drying time in the manual) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is limited to units associated with the Spanish Operators Manual, part number 60905771.
The recall was initiated because the 36 kHz Sterilization Tray system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes as the minimum Dry Time for the 36 kHz Sterilization Tray and components, but 40 minutes is required for complete drying.
The affected products were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. Users should stop using the affected manual and refer to the corrected drying time of 40 minutes for the 36 kHz Sterilization Tray and components.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- 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)
- Spanish OPS Manual P/N 60905771
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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