Devices

Device Recall LICOX Brain Oxygen Monitoring System

Model / Serial
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
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Foreign
Product Description
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
Manufacturer
Integra LifeSciences Corp.
1 Event
- Recall of Device Recall LICOX Brain Oxygen Monitoring System

Manufacturer

Integra LifeSciences Corp.

Manufacturer Address
Integra LifeSciences Corp., 311 Enterprise Dr, Plainsboro NJ 08536-3344
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

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