FDA Recall
Terminated
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.
Recall: Z-1620-2015
·
Initiated April 14, 2015
Recall
- Recall Number
- Z-1620-2015
- Event Number
- 71027
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- GWM
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 14, 2015
- Posted
- May 15, 2015
- Terminated
- December 12, 2017
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344
Description
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.
Reason
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.
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.
Distribution
Worldwide Distribution.
Quantity
59 monitors