C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reported: December 18, 2019 Initiated: October 21, 2019 #Z-0613-2020
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.
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 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
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System. Recalled by Integra LifeSciences Corp.. Units affected: 820.
Why was this product 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 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0613-2020.
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