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INTEGRA LIFESCIENCES (IRELAND) LIMITED devices, product family

by INTEGRA LIFESCIENCES (IRELAND) LIMITED 24 variants Basic UDI-DI 038178B0036CSS3D

Shared by every variant

Manufacturer
INTEGRA LIFESCIENCES (IRELAND) LIMITED(24)
Basic UDI-DI
038178B0036CSS3D
Risk class
Class IIUnclassified (varies)
Legislation
—
EMDN category
—
Market status
24 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 038178B0036CSS3D.

Recalls

17 recalls · FDA

  • Z-1620-2015 Class II · terminated · 14 Apr 2015
    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
  • Z-1619-2015 Class II · terminated · 14 Apr 2015
    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
  • Z-1618-2015 Class II · terminated · 14 Apr 2015
    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
  • Z-0831-2015 Class II · terminated · 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.
  • Z-0063-2014 Class II · terminated · 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.
  • Z-0060-2014 Class II · terminated · 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.
  • Z-0057-2014 Class II · terminated · 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.
  • Z-0055-2014 Class II · terminated · 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.
  • Z-0054-2014 Class II · terminated · 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.
  • Z-0059-2014 Class II · terminated · 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.
  • Z-0061-2014 Class II · terminated · 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.
  • Z-0056-2014 Class II · terminated · 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.
  • Z-0062-2014 Class II · terminated · 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.
  • Z-1518-2011 unclassified · terminated · 17 Dec 2010
    Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
  • Z-0161-2011 unclassified · terminated · 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).
  • Z-1422-2010 unclassified · terminated · 18 Feb 2010
    One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
  • Z-0622-05 unclassified · terminated · 21 Jan 2005
    LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

Recalls matched to the 24 devices listed on this page; other pages of the family can carry others.

Variants

24 devices · page 1 of 1

Variants of INTEGRA LIFESCIENCES (IRELAND) LIMITED devices, Basic UDI-DI 038178B0036CSS3D
UDI-DISize and differences
Camino® EXPORTCAB EXPORTCAB / EXPORTCAB10381780121886
Single use: no
On the market
CUSA® Excel C4608S C4608S / C4608S10381780025993
Single use: yes
On the market
Integra® ICP-16 ICP-16 / ICP-1610381780039679
Single use: no
On the market
Integra® ICP-17 ICP-17 / ICP-1710381780039686
Single use: no
On the market
Integra® ICP-18 ICP-18 / ICP-1810381780039693
Single use: no
On the market
Integra® ICP-19 ICP-19 / ICP-1910381780039709
Single use: no
On the market
Integra® ICP-22 ICP-22 / ICP-2210381780039716
Single use: no
On the market
Integra® ICP-33 ICP-33 / ICP-3310381780039723
Single use: no
On the market
Integra® ICP-46 ICP-46 / ICP-4610381780039747
Single use: no
On the market
Integra® ICP-60 ICP-60 / ICP-6010381780039761
Single use: no
On the market
Integra® ICP-80 ICP-80 / ICP-8010381780039778
Single use: no
On the market
Integra® ICP-81 ICP-81 / ICP-8110381780039785
Single use: no
On the market
Integra® ICP-90 ICP-90 / ICP-9010381780039792
Single use: no
On the market
Integra® ICT-01 ICT-01 / ICT-0110381780039808
Single use: no
On the market
Integra® ICT-39 ICT-39 / ICT-3910381780039815
Single use: no
On the market
Integra® PMIOMPM-1 PMIOMPM-1 / PMIOMPM-110381780466291
Single use: no
On the market
Licox® BC10 BC10 / BC1010381780250128
Single use: no
On the market
Licox® BC10PA BC10PA / BC10PA10381780250050
Single use: no
On the market
Licox® BC10PMO BC10PMO / BC10PMO10381780250074
Single use: no
On the market
Licox® BC10PV BC10PV / BC10PV10381780250067
Single use: no
On the market
Licox® BC10R BC10R / BC10R10381780250111
Single use: no
On the market
Licox® BC10TA BC10TA / BC10TA10381780250081
Single use: no
On the market
Licox® BC10TV BC10TV / BC10TV10381780250104
Single use: no
On the market
Licox® PMOCAB PMOCAB / PMOCAB10381780250043
Single use: no
On the market