| Class 2 Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit | |
Date Initiated by Firm | June 11, 2013 |
Date Posted | October 23, 2013 |
Recall Status1 |
Terminated 3 on February 18, 2014 |
Recall Number | Z-0058-2014 |
Recall Event ID |
65742 |
Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
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Product | Integra 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
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For Additional Information Contact | Mr. 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 |
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 | 175 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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