Class 2 Device Recall Integra Licox Pt02 Monitors

• Date Initiated by Firm: April 14, 2015
• Date Posted: May 15, 2015
• Recall Status: Terminated on December 12, 2017
• Recall Number: Z-1619-2015
• Recall Event ID: 71027
• 510(K)Number: K121573 K131184
• Product Classification: Device, monitoring, intracranial pressure - Product Code GWM
• Product: The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
• Code Information: All Lots
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Mr. David E. Gronostajski; 609-936-6822
• Manufacturer Reason for Recall: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
• FDA Determined Cause: Device Design
• Action: Integra initiated this recall by sending an Urgent Voluntary Medical Device Recall Letter/Recall Acknowledgement Form dated 4/14/15 via traceable courier service to their affected customers.
• Quantity in Commerce: 273 monitors
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = GWM; 510(K)s with Product Code = GWM