Integra LifeSciences Corp. Recall: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Integra LifeSciences Corp. Recall: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Integra LifeSciences Corp.; Product: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System; Reason for recall: The 36 kHz Sterilization Tray (C71
| Recalling firm | Integra LifeSciences Corp. |
|---|---|
| Product | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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 initiated | 20191021 |
| Recall number | Z-0644-2020 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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