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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit

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  Class 2 Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit see related information
Date Initiated by Firm June 11, 2013
Date Posted October 23, 2013
Recall Status1 Terminated 3 on February 18, 2014
Recall Number Z-0061-2014
Recall Event ID 65742
510(K)Number K040235  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
Product Integra Licox Brain Tissue Oxygen Monitoring
1 x Dual Lumen Introducer Kit
REF IM2.S_.EU

Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany
Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA

Used in direct monitoring of the partial pressure of oxygen.
Code Information Lot # 030912, 110612, 170812, 230812
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Mr. Srinivas Balusu
609-936-2464
Manufacturer Reason
for Recall		 Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
Quantity in Commerce 695 units (US and Foreign)
Distribution Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
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 CORPORATION
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