Integra LifeSciences Corp. recalls C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Recall date

October 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0654-2020

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System