Z-0613-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- October 21, 2019
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 820
Product Description
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason for Recall
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 Operator s 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.
Distribution Pattern
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
Code Information
US Ops Manual P/N 60905769