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Terminated

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

FDA Recall Z-0831-2015 · Posted 2014-12-18

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGWM
Date Initiated2014-11-07
Date Terminated2015-08-11
Product Quantity2,506 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide, Foreign

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KITIntegra Lifesciences Corp. · 2006-05-10K040235LICOX PMO BRAIN MONITORING SYSTEMIntegra LifeSciences Corporation · 2004-04-20K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPEIntegra Neurosciences · 2000-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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