Date Initiated by Firm |
April 14, 2015 |
Date Posted |
May 15, 2015 |
Recall Status1 |
Terminated 3 on December 12, 2017 |
Recall Number |
Z-1619-2015 |
Recall Event ID |
71027 |
510(K)Number |
K131184 K121573
|
Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
|
Product |
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue. |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
|
For Additional Information Contact |
Mr. David E. Gronostajski 609-936-6822
|
Manufacturer Reason for Recall |
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
|
FDA Determined Cause 2 |
Device Design |
Action |
Integra initiated this recall by sending an Urgent Voluntary Medical Device Recall Letter/Recall Acknowledgement Form dated 4/14/15 via traceable courier service to their affected customers. |
Quantity in Commerce |
273 monitors |
Distribution |
Worldwide Distribution. |
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.
|
510(K) Database |
510(K)s with Product Code = GWM and Original Applicant = INTEGRA LIFESCIENCES CORP. 510(K)s with Product Code = GWM and Original Applicant = INTRGRA LIFESCIENCES CORPORATION
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