Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the sterilization process may be compromised due to incorrect drying time instructions, posing a risk of harm, but no specific injuries or illnesses have been reported 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 is due to a discrepancy in the drying time for the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system. The current CUSA Clarity Operators manual states a minimum dry time of 30 minutes for the 36 kHz Sterilization Tray and components, but 40 minutes is actually required 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 Chinese-Simplified OPS Manual P/N 60905206.
Healthcare providers and consumers should stop using the affected sterilization trays and contact Integra LifeSciences Corp. for further instructions on how to proceed with the recall.
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)
- Chinese-Simplified OPS Manual P/N 60905206
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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