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Csk Electrode
- Starting date:
- July 10, 2017
- Posting date:
- August 15, 2017
- 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-64228
Reason
There have been complaints that after multiple reprocessing cycles, the epoxy resin which holds the TCN electrode can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device. The failure to completely remove any blood and/or tissue from the TCN electrodes prior to re-sterilization creates a potential risk of infection and spread of blood borne pathogens to patients.
Affected products
Csk Electrode
Lot or serial number
Not Applicable
Model or catalog number
TCN-10
Companies
- Manufacturer
-
COSMAN MEDICAL, INC.
22 Terry Avenue
Burlington
01803
Massachusetts
UNITED STATES