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Class 2 Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit |
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Date Initiated by Firm |
June 11, 2013 |
Date Posted |
October 23, 2013 |
Recall Status1 |
Terminated 3 on February 18, 2014 |
Recall Number |
Z-0057-2014 |
Recall Event ID |
65742 |
510(K)Number |
K040235
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Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
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Product |
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2
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.
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Code Information |
K040244 Lot #190712; 240512;280612 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
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For Additional Information Contact |
Mr. Srinivas Balusu 609-936-2464
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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.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile. |
Quantity in Commerce |
109 kits |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = GWM and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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