Integra CUSA Clarity System Recall for Sterilization Tray Drying Time Error
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the Polish OPS Manual incorrectly states the minimum drying time for the 36 kHz Sterilization Tray.
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: This is a Class II recall involving a documentation error in the operator's manual regarding sterilization drying times. It is classified as Moderate because it is a labeling/documentation issue without reported injuries or illnesses.
Plain-English summary
Integra LifeSciences Corp. is recalling the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is limited to the Polish OPS Manual (P/N 60905785) distributed in the United States and internationally.
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 for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components, but 40 minutes is required for complete drying.
The affected manual was distributed in the following US states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, UT, VA, WA, WI, WV. It was also distributed internationally in SG, MX, CA, JP, AU, CO, TH, and HK. Users should verify the drying time requirements for the 36 kHz Sterilization Tray and 36 kHz Components to ensure complete drying.
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 60905785
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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