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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.

FDA Recall Z-1620-2015 · Posted 2015-05-15

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeGWM
Date Initiated2015-04-14
Date Terminated2017-12-12
Product Quantity59 monitors

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131184INTEGRA LICOX PTO2 MONITORIntegra Lifesciences Corp. · 2013-08-30K121573INTEGRA CAMINO ICP MONITORIntrgra Lifesciences Corporation · 2012-09-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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