Recall Z-1619-2015— Integra LifeSciences Corp.

Name: FDA recall Z-1619-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-14

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2015-04-14, terminated 2017-12-12. It names 2 FDA 510(k) clearances: K131184, K121573. 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.. 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Terminated: 2017-12-12
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K131184 — INTEGRA LICOX PTO2 MONITORIntegra Lifesciences Corp.·cleared 2013-08-30
K121573 — INTEGRA CAMINO ICP MONITORIntrgra Lifesciences Corporation·cleared 2012-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.