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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-0054-2014
Recall Event ID 65742
510(K)NumberK040235 
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
ProductIntegra 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.
Code Information K040235  Lot 160812
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 Commerce21 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.
510(K) Database510(K)s with Product Code = GWM
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