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Integra LifeSciences Corp. recalls Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- G
Recalled October 30, 2013 · FDA recall Z-0060-2014 · Integra LifeSciences
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. · FDA Class II
Units
42 Kits non US
Sold at
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.
Description
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.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU 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(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →