Recall Z-0618-2020 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
| Date | Oct 21, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | All impacted consignees (Hospitals, Distributors and Sales reps) were notified by letter delivered by courier service (2nd day), facsimile or email between October 21st and 23rd, 2019. URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION CUSA Clarity Operators Manual Dear Valued Customer/Distributor: The purpose of this letter is to advise you that Integra LifeSciences is voluntarily conducting this field corrective action for the Operators Manuals associated with C7000 CUSA Clarity Console. It was discovered through internal review that we need to revise the Operators Manual to reflect the most accu |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System Integra LifeSciences Corporation, Dec 7, 2018 |