FDA-Device2013-10-30Class II
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.
Integra LifeSciences Corp.
Hazard
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.
Sold states
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.
Affected count
503 kits(482 US; 21 non US)
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0056-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief