Recall Z-0831-2015 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
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
| Date | Dec 18, 2014 (initiated Nov 7, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 2,506 units |
| Distribution | Nationwide, Foreign |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE Integra Neurosciences, Nov 24, 2000 |
| K040235 | LICOX PMO BRAIN MONITORING SYSTEM Integra LifeSciences Corporation, Apr 20, 2004 |
| K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT Integra Lifesciences Corp., May 10, 2006 |