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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Licox Pt02 Monitor

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  Class 2 Device Recall Integra Licox Pt02 Monitor see related information
Date Initiated by Firm August 18, 2014
Date Posted November 10, 2014
Recall Status1 Terminated 3 on May 11, 2016
Recall Number Z-0201-2015
Recall Event ID 69251
510(K)Number K131184  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
Product Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Code Information Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.
Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Mr. David E. Gronostajski
Manufacturer Reason
for Recall
Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.
FDA Determined
Cause 2
Device Design
Action Integra LifeSciences sent an "Urgent Voluntary Medical Device Correction" letter/Return Response Form dated August 18, 2014, to their affected customers via traceable courier service. The letter identified the product the problem and the action needed to be taken by the customer. Complete the attached form. If you do not have an affected monitor, check the box: I do not have any monitors with an affected Serial Number listed below. If you do have affected monitors, check the box: I do have monitors with an affected Serial Number listed below. Circle all the Serial Numbers for the affected monitors you have and record the total quantity. Complete the other information on the form and return the form by email or fax as indicated. Keep a copy of the form for your records. When your form is received, Integra will schedule this service with your facility and provide a temporary loaner monitor to minimize any disruption this action may cause. Should you have any questions, please contact Neuro Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.
Quantity in Commerce 43 (LCX02) and 17 (LCX02R)
Distribution US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GWM and Original Applicant = INTEGRA LIFESCIENCES CORP.