Recall Z-1620-2015— Integra LifeSciences Corp.

Name: FDA recall Z-1620-2015
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 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..

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 LCX02R monitor measures and displays oxygen partial pressure and temperature in 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.