Date Initiated by Firm | April 14, 2015 |
Date Posted | May 15, 2015 |
Recall Status1 |
Terminated 3 on December 12, 2017 |
Recall Number | Z-1620-2015 |
Recall Event ID |
71027 |
510(K)Number | K121573 K131184 |
Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
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Product | The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.
The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue. |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
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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 | 59 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.
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510(K) Database | 510(K)s with Product Code = GWM 510(K)s with Product Code = GWM
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