Z-1518-2011

LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische...

Name: Z-1518-2011 LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische...
Creator: Integra LifeSciences Corp.
Published: 2010-12-17
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-12-17 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf... on 2010-12-17. The reason FDA records is "Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1518-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-03-03
Terminated: 2012-11-05
Recalling firm: Integra LifeSciences Corporation
Product: LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, New Jersey 08536 USA. Used for continuous determination of oxygen partial pressure in cerebrospinal fluid and brain tissue.
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Integra Life Sciences notified their Integra Neurospecialist via email and their customers via Fed Ex overnight mail on December 17, 2010 with an Urgent: Product Recall letter. The letter identified the affected product and the reason for the recall. The letter states that an Integra Neurospecialist will contact customers to arrange for the return of their Licox monitor to the Service Center for recalibration. A loaner will be provided until the recalibration is complete. The attached "Recall Acknowledgement and Return Form" must be completed and returned to Integra. If there are any additional questions, customers should contact Gary Rabinovich at 609-936-6864.
Quantity in commerce: 26 units
Distribution: Worldwide Distribution
Product codes and lots: Lot/Serial numbers: 1982, 1988, 1990, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2003, 2005, 2007, 2008, 2009, 2010, 2011, 2012, 2014, 2046, 2047, 2051, and 2053.

Product code GWM

K002765Class IILicox Cmp Monitor-Ac3.1, Licox Imc Oxygen Catheters-Cc1,cc1.sb Luicox Imc Introducer Kits-Im,im2,im3,ii1 Licoximc TempeIntegra Neurosciences / cleared 2000-11-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)