Licox® IP1

• FDA 510(k) K040235 decided 20 Apr 2004 Active
• FDA GUDID UDI-DI 10381780250302 listed 4 Aug 2016 Listed

• • Terminated Z-0831-2015 FDA Class II ·initiated 7 Nov 2014

  Due to a complaint, it was determined that multiple lots of Licox catheters manufactured since October 29, 2013 contained a smart card which was programmed with an inaccurate lkN2 value.

• 9 recalls, same reason

  • Terminated Z-0061-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0056-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0062-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0063-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0060-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0057-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0055-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0054-2014 FDA Class II ·initiated 11 Jun 2013
  • Terminated Z-0059-2014 FDA Class II ·initiated 11 Jun 2013

  Integra LifeSciences Corporation has determined that there is a possibility that some lots of Licox CMP Brain Tissue Oxygen and Temperature Catheter Kits contain a hex wrench that does not loosen the set screw on the drill bit.

• • Terminated Z-0161-2011 FDA Unclassified (pre-2012) ·initiated 15 Sep 2010

  Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long).

• • Terminated Z-1422-2010 FDA Unclassified (pre-2012) ·initiated 18 Feb 2010

  One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.

1. 11 Jun 2013 Recall initiated FDA recalls Z-0056-2014
2. 11 Jun 2013 Recall initiated FDA recalls Z-0062-2014
3. 11 Jun 2013 Recall initiated FDA recalls Z-0063-2014
4. 11 Jun 2013 Recall initiated FDA recalls Z-0060-2014
5. 11 Jun 2013 Recall initiated FDA recalls Z-0057-2014
6. 11 Jun 2013 Recall initiated FDA recalls Z-0055-2014
7. 11 Jun 2013 Recall initiated FDA recalls Z-0054-2014
8. 11 Jun 2013 Recall initiated FDA recalls Z-0059-2014
9. 7 Nov 2014 Recall initiated FDA recalls Z-0831-2015
10. 4 Aug 2016 Listed FDA GUDID 10381780250302

4 earlier events are in the sections above.

Trade name

Licox®

Generic name

Neurosurgical procedure kit, non-medicated, single-use

Model / Ref / Catalog

IP1

Primary DI / UDI-DI

10381780250302

FDA product code

GWM

GMDN term

Neurosurgical procedure kit, non-medicated, single-use

Device class

Class II

Regulation number

882.1620

GUDID distribution status

In Commercial Distribution

Category: Neurosurgical procedure kit, non-medicated, single-use

Other devices filed under FDA product code GWM (DEVICE, MONITORING, INTRACRANIAL PRESSURE).

• CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 by INTEGRA NEUROSCIENCES
• MPR2 logO DATALOGGER by RAUMEDIC AG
• INTEGRA CAMINO ICP MONITOR by Intrgra Lifesciences Corporation
• OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE by Innerspace Medical, Inc.
• LICOX PMO BRAIN MONITORING SYSTEM by Integra Lifesciences Corporation
• CODMAN® 826608 82-6608 by Integra LifeSciences Production Corporation
• MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL by Medtronic PS Medical
• Pressio 2 ICP Monitoring System by Sophysa SA
• Transpac II Disposable Transducer by Abbott Laboratories
• CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) by Integra LifeSciences Production Corporation

• Codman® 9190001GF

  Class II

  FDA 510(k) K163106 Active Cleared 1 Dec 2016 GUDID on market

• Codman® Certas® 828801PL Open recall

  Class II

  FDA 510(k) K223330 Active Cleared 1 Feb 2023 GUDID on market

• Osv II® 909702

  Class II

  GUDID on market

• Codman® Certas® 828821PL Open recall

  Class II

  FDA 510(k) K223330 Active Cleared 1 Feb 2023 GUDID on market

See all devices from Integra LifeSciences Switzerland Sàrl →