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.
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: The recall is classified as FDA Class II. The hazard involves a documentation error regarding drying time, which is a low-risk contamination or labeling issue without reported injuries, fitting the Moderate severity criteria.
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). The current operator's manual states that a 30-minute cycle is sufficient for complete drying, but testing indicates that 40 minutes are required to meet the Dry Time Criteria.
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 Portuguese OPS Manual, P/N 60905779.
Healthcare facilities and users should stop using the affected sterilization trays 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)
- Portuguese OPS Manual P/N 60905779
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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