CLASS II Device recall · Reported 27 May 2015 · FDA Enforcement Report

The Integra Camino ICP Monitor is a compact recalled

Integra LifeSciences is recalling The Integra Camino ICP Monitor is a compact, portable device for use with. The recall was initiated on 14 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalled1,482 monitors

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1618-2015
FDA event ID: 71027
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 14 Apr 2015
FDA classified: 15 May 2015
Reported: 27 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

14 Apr 2015	Recall initiated by company
15 May 2015	Classified by FDA	+31 days
27 May 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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).

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it 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.

Which lots are affected?

All Lots

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 71027

This product is part of a recall event; the main page for the event is The Integra Licox Pt02 Monitors are compact recalled.

Reported	Class	Recall	Company	Reason	Where
27 May 2015	CLASS II	The Integra Licox Pt02 Monitors are compact recalled	Integra LifeSciences	Device Malfunction	NJ
27 May 2015	CLASS II	The Integra Licox Pt02 Monitors are compact recalled	Integra LifeSciences	Device Malfunction	NJ

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