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Devices
Device Recall Integra Licox
Model / Serial
Catalog number CC1P1, Serial number SN 776; Lot number 160110A
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
One hospital in Omaha, NE.
Product Description
Integra, Licox Ref 1P2.P; || Brain PMO-Probe Kit || Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, || REF CC1/P1 Combined Oxygen & Temperature Probe. || Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
Manufacturer
Integra LifeSciences Corp.
1 Event
Recall of Device Recall Integra Licox
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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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Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit
Model / Serial
K040235 Lot 160812
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Product Description
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit || REF IP1.P || Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany || Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. || Used in direct monitoring of the partial pressure of oxygen.
Manufacturer
Integra LifeSciences Corp.
Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit
Model / Serial
K040235 Lot #020712;040912;050712;080612;110912;120912;140612;290812
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Product Description
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit || REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany || Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA. || Used in direct monitoring of the partial pressure of oxygen.
Manufacturer
Integra LifeSciences Corp.
Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit
Model / Serial
K040235 Lot #020812l 050712; 070612; 090812; 140612;173419; 173438; 173515; 173538; 173540; 173720; 173725; 173887; 173918; 190712; 210612; 230812; 260712
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Product Description
Integra Licox Brain Tissue Oxygen Monitoring || 1 x Complete Brain Probe Kit || REF IP2.P || Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany || Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA || Used in direct monitoring of the partial pressure of oxygen.
Manufacturer
Integra LifeSciences Corp.
Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit
Model / Serial
K040244 Lot #190712; 240512;280612
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Product Description
Inegra Licox Brain Tissue Oxygen Monitoring || 1 x Complete Brain Tunneling Probe Kit || REF IT2 || Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany || Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA || Used in direct monitoring of the partial pressure of oxygen.
Manufacturer
Integra LifeSciences Corp.
Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit
Model / Serial
K002765 Lot # 130712, 210912, 220612, 172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
Product Description
Integra Licox Brain Tissue Oxygen Monitoring || 1 x Complete Brain Probe Kit || REF IM3.SR || Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany || Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA || Used in direct monitoring of the partial pressure of oxygen.
Manufacturer
Integra LifeSciences Corp.
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