Integra CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes 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 procedural discrepancy in drying time that could impact sterilization efficacy, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
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 required for the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) and its components.
The current CUSA Clarity Operators manual states that 30 minutes is the minimum dry time for the 36 kHz Sterilization Tray and components. However, the system does not meet the Dry Time Criteria for a 30-minute cycle; 40 minutes is required for complete drying. This issue could affect the sterilization process if the equipment is used according to the manual's current instructions.
The affected units were distributed in the United States and internationally. Users of this equipment should contact Integra LifeSciences Corp. for further instructions on how to proceed with the recall and any necessary manual updates.
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)
- Swedish OPS Manual P/N 60905774
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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