Integra LifeSciences Corp. recalls The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Par…
- Recall date
- April 14, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1619-2015
- FDA classification
- Class II
- Brand / firm
- Integra LifeSciences Corp.
- Sold / distributed
- Worldwide Distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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