C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reported: December 18, 2019 Initiated: October 21, 2019 #Z-0624-2020
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 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.
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 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0624-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11