Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit

K040235  Lot 160812

Neurological Devices

2

No

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.

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.

K040235  Lot #020712;040912;050712;080612;110912;120912;140612;290812

Neurological Devices

2

No

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.

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.

K040244  Lot #190712; 240512;280612

Neurological Devices

2

No

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.

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.

K002765 Lot # 130712, 210912, 220612,  172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942

Neurological Devices

2

No

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.

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.

K002765 Lot # 090812, 170812

Neurological Devices

2

No

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.

Integra Licox Brain Tissue Oxygen Monitoring || 1 x Complete Brain Probe Kit || REF IM1.S || 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.