Recalls / —
—#135878
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.
- FDA product code
- GWM — Device, Monitoring, Intracranial Pressure
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K121573, K131184
- Affected lot / code info
- All Lots
Why it was recalled
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.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2015-04-14
- Posted by FDA
- 2015-05-15
- Terminated
- 2017-12-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #135878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.