Z-0620-2020 Class II Terminated
FDA device recall Z-0620-2020 was initiated by Integra LifeSciences Corp. on October 21, 2019 and is designated Class II. 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 Operators manual states 30 minutes for th… The recall status is terminated (terminated May 7, 2020). Affected quantity: 820.
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 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.
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
Spanish OPS Manual P/N 60905199