Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
What this means for you
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a procedural discrepancy regarding drying time, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
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 discrepancy in the drying time requirements for the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A). The current operator's manual states a minimum dry time of 30 minutes, but the system requires 40 minutes for complete drying.
The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. The specific code information associated with the recall is the French OPS Manual P/N 60905198.
Healthcare providers and users should stop using the affected 36 kHz Sterilization Tray and contact Integra LifeSciences for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
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)
- French OPS Manual P/N 60905198
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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