PlainRecalls
FDA Devices Moderate Class II Terminated

The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).

Reported: May 27, 2015 Initiated: April 14, 2015 #Z-1618-2015

Product Description

The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).

Reason for Recall

Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

Details

Units Affected
1,482 monitors
Distribution
Worldwide Distribution.
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).. Recalled by Integra LifeSciences Corp.. Units affected: 1,482 monitors.
Why was this product recalled?
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 27, 2015. Severity: Moderate. Recall number: Z-1618-2015.