Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray fails to 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. The hazard involves a discrepancy between the stated drying time and the actual time required for complete drying, which is a procedural defect without reported injuries or illnesses in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) and the Russian OPS Manual (P/N 60905775). The affected units were distributed in the United States and internationally in Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong.
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 36 kHz Components, but 40 minutes is actually required for complete drying.
Healthcare facilities and users of the C7000 CUSA Clarity System should stop using the affected sterilization trays and contact Integra LifeSciences Corp. for further instructions.
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)
- Russian OPS Manual P/N 60905775
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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