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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit

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 Class 2 Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kitsee related information
Date Initiated by FirmJune 11, 2013
Date PostedOctober 23, 2013
Recall Status1 Terminated 3 on February 18, 2014
Recall NumberZ-0058-2014
Recall Event ID 65742
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
ProductIntegra 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.
Code Information K002765 Lot # 130712, 210912, 220612,  172281, 172647, 172690, 173170, 173260, 173548, 173580, 173917, 173942
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactMr. Srinivas Balusu
609-936-2464
Manufacturer Reason
for Recall
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 Determined
Cause 2
Nonconforming Material/Component
ActionIntegra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
Quantity in Commerce175 KITS
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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