Device product
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.
Z-0056-2014
Product summary
- Event
- Event 65742
- Status
- Terminated
- Classification
- Class II
- Quantity
- 503 kits(482 US; 21 non US)
- Official record key
device-enforcement:Z-0056-2014
Official wording
Reason: Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.
Code information: K040235 Lot #020812l 050712; 070612; 090812; 140612;173419; 173438; 173515; 173538; 173540; 173720; 173725; 173887; 173918; 190712; 210612; 230812; 260712
Distribution pattern: 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.
Derived failure modes
-
Unknown
Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.