C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System recall
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Why was C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System recalled?
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Chinese-Simplified OPS Manual P/N 60905778
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 820
- Distribution
- US: 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 International: SG MX CA JP AU CO TH HK
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)