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Class 2 Device Recall LICOX Brain Oxygen Monitoring System |
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Date Initiated by Firm |
November 07, 2014 |
Date Posted |
December 18, 2014 |
Recall Status1 |
Terminated 3 on August 11, 2015 |
Recall Number |
Z-0831-2015 |
Recall Event ID |
69803 |
510(K)Number |
K040235 K053244 K002765
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Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
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Product |
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring
1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB)
Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247
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Code Information |
CC1 Licox¿ PO2 Microprobe, 200 mm 021213, 040414, 070314, 130114, 240214, 270114, 280314, 300614 CC12 Licox¿ PO2 Microprobe, 300 mm 020614, 040814, 050514, 070414, 070714, 220414 CC1.P1 Licox¿ PMO Combined Probe Containing Oxygen and Temperature 050614, 060214, 060314, 100414, 100714, 130214, 130314, 170114, 190614, 210814, 260614, 310714 IM3ST Licox¿ Complete Brain IMC-Probe Kit: 020614, 030314, 110714, 130114, 140314, 160614, 180714, 200114, 280314 IP1.P Licox¿ Single Lumen Bolt CMPS and Temperature Bolt Kit 030714, 060214, 060314, 070814, 080514, 100714, 120614, 130314, 190614, 310714 IP2.P Licox¿ Double Lumen Bolt CMPS, Temperature and ICP Monitoring Kit 030714, 050614, 060214, 060314, 070814, 080514, 090114, 100714, 130314, 140814, 200214, 200414, 260614, 290814 IT2 Licox¿ Tunneling CMPS and Temperature Monitoring Kit 090114, 100414, 190614, 200214, 260614, 310714 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
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For Additional Information Contact |
Mr. David E. Gronostajski 609-936-6822
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Manufacturer Reason for Recall |
Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.
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FDA Determined Cause 2 |
Device Design |
Action |
Integra sent Urgent- Voluntary Medical Device Recall Letters/Recall Acknowledgement and Return Form dated 11/7/2014 to customers and distributors via traceable courier service. |
Quantity in Commerce |
2,506 units |
Distribution |
Nationwide, Foreign |
Total Product Life Cycle |
TPLC Device Report
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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.
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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 = INTEGRA LIFESCIENCES CORPORATION 510(K)s with Product Code = GWM and Original Applicant = INTEGRA NEUROSCIENCES
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