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Health product recall

LICOX Brain Tissue Oxygen Monitoring Systems (2014-11-07)

Starting date:
November 7, 2014
Posting date:
January 14, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43285

Recalled Products

A) LICOX Micro-Probe Kit
B) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Probe Kit
C) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Tunneling Probe Kit
D) Combined Oxygen and Temperature Probe
E) Oxygen Probe

Reason

Integra Lifesciences initiated a recall to remove all affected LICOX probes and probe kits that may contain an inaccurate smart cards supplied with the subject devices. The IKN2 value in approximately 90% of the potentially affected cards is approximately 10 times higher than it should be resulting in varying degrees of understated PO2 values (from -1 mm of Hg to -7 mm of Hg) when the probes are used.

Affected products

A) LICOX Micro-Probe Kit

Lot or serial number

All lots.

Model or catalog number

IM1.S
IM3.S
IM3.ST

Companies
Manufacturer
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY

B) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Probe Kit  

Lot or serial number

All lots.

Model or catalog number

IP1.P
IP2.P

Companies
Manufacturer
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY

C) LICOX Brain Tissue Oxygen Monitoring System - Complete Brain Tunneling Probe Kit

Lot or serial number

All lots.

Model or catalog number

IT2

Companies
Manufacturer
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY

D) Combined Oxygen and Temperature Probe

Lot or serial number

All lots.

Model or catalog number

CC1.P1

Companies
Manufacturer
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY

E) Oxygen Probe

Lot or serial number

All lots.

Model or catalog number

CC1.SB

Companies
Manufacturer
GMS-Gesellschaft Fur Medizinische Sondentechnik MBH
Dorfstrasse 2, Mielkendorf,
Kiel, Schleswig-Holstein
24247
GERMANY