The Recall Desk
ModerateFDA (Devices)·Z-1620-2015·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional malfunction (speaker) rather than a direct physical injury or contamination risk, fitting the criteria for moderate severity.

Plain-English summary

Integra LifeSciences Corporation is recalling the Camino ICP Monitor (CAM 02) and Licox PtO2 Monitor (LCX02 & LCX02R). The recall is being conducted due to complaints that the audible speaker on these devices malfunctions.

The affected products are compact, portable devices used with specific transducer-tipped catheters to measure and display pressure, temperature, and oxygen partial pressure in tissue. The recall covers 59 monitors distributed worldwide.

Users of these devices should contact Integra LifeSciences Corporation for further instructions regarding the malfunctioning speaker.

The recalled product

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.
Affected units
59

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →