Integra LifeSciences Recalls C7000 CUSA Clarity Sterilization Tray
Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
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 times, 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 the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System, specifically the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A). The recall is due to a discrepancy in the CUSA Clarity Operators manual regarding drying times. The manual states that 30 minutes is the minimum dry time for the 36 kHz Sterilization Tray and components, but the system actually requires 40 minutes for complete drying.
The affected product is the Polish OPS Manual (P/N 60905213). The recall covers distribution in the United States and several international locations, including Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. The source text does not specify the number of units affected or report any illnesses or injuries.
Healthcare facilities and users should stop using the affected sterilization tray and manual. They should contact Integra LifeSciences Corp. for further instructions on how to proceed with the recall and obtain corrected documentation.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
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)
- Polish OPS Manual P/N 60905213
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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