Recall Z-0625-2020— Integra LifeSciences Corp.

Name: FDA recall Z-0625-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-21

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2019-10-21, terminated 2020-05-07. It names one FDA 510(k) clearance: K182809. Product: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System. 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2019-10-21
Terminated: 2020-05-07
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K182809 — CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation·cleared 2018-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.