Z-1618-2015Class II

The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and...

Name: Z-1618-2015 The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and...
Creator: Integra LifeSciences Corp.
Published: 2015-04-14
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2015-04-14 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped... on 2015-04-14. FDA classified it as Class II and gives the reason as "Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1618-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Posted: 2015-05-15
Terminated: 2017-12-12
Recalling firm: Integra LifeSciences Corporation
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).
Product code: GWM Device, Monitoring, Intracranial Pressure
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1,482 monitors
Distribution: Worldwide Distribution.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1618-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1618-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-15
Z-1619-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-15
Z-1620-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-15

Product code GWM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)