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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Camino ICP Monitor

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  Class 2 Device Recall Integra Camino ICP Monitor see related information
Date Initiated by Firm April 14, 2015
Date Posted May 15, 2015
Recall Status1 Terminated 3 on December 12, 2017
Recall Number Z-1618-2015
Recall Event ID 71027
510(K)Number K131184  K121573  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
Product The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.

The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
Code Information All Lots
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 (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
FDA Determined
Cause 2		 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 1,482 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 and Original Applicant = INTEGRA LIFESCIENCES CORP.
510(K)s with Product Code = GWM and Original Applicant = INTRGRA LIFESCIENCES CORPORATION
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