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TCM TOSCA/COMBIM-TC SENSORS (2015-06-24)
- Starting date:
- June 24, 2015
- Posting date:
- July 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54316
Affected Products
- TCM TOSCA/COMBIM - TC SENSOR 54
- TCM TOSCA/COMBIM - TC SENSOR 84
Reason
It has been discovered that the adhesive properties of the fixation kit N20 at the interface to the patient's skin is impaired and in some cases deemed to be inadequate.
Affected products
A. TCM TOSCA/COMBIM - TC SENSOR 54
Lot or serial number
>10 CONTACT MFR
Model or catalog number
945-736
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK
B. TCM TOSCA/COMBIM - TC SENSOR 84
Lot or serial number
>10 CONTACT MFR
Model or catalog number
945-737
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK