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U.S. Department of Health and Human Services

Class 2 Device Recall LICOX Brain Oxygen Monitoring System

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 Class 2 Device Recall LICOX Brain Oxygen Monitoring Systemsee related information
Date Initiated by FirmNovember 07, 2014
Date PostedDecember 18, 2014
Recall Status1 Terminated 3 on August 11, 2015
Recall NumberZ-0831-2015
Recall Event ID 69803
510(K)NumberK002765 K040235 K053244 
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
ProductIntegra 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
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
For Additional Information ContactMr. David E. Gronostajski
609-936-6822
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.
FDA Determined
Cause 2		Device Design
ActionIntegra 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 Commerce2,506 units
DistributionNationwide, Foreign
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GWM
510(K)s with Product Code = GWM
510(K)s with Product Code = GWM
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