The Recall Desk

FDA (Devices) recall action 71027

Integra LifeSciences Corp. recalled 3 products on 2015-05-27

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2015-05-27
Critical
0
Units
1,814

Why these products were 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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2015-05-27

    Integra Recalls Camino ICP Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.

    Product
    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).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speakers may malfunction.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speaker malfunctions.

    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.
    Category
    Distribution
    0 states