FDA Enforcement
Class II
Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Recall: Z-0634-2020
·
Reported December 18, 2019
Enforcement
- Recall Number
- Z-0634-2020
- Event ID
- 84216
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2019
- Initiation Date
- October 21, 2019
- Classification Date
- December 8, 2019
- Termination Date
- May 7, 2020
- Address
- 311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States
Description
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason
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.
Code Info
Chinese-Simplified OPS Manual P/N 60905206
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
Quantity
820