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Type of Product
Medical Device
TGA Recall Reference
RC-2015-RN-01102-1
Product Name/Description
ECG Electrode SKINTACT W-60
Catalogue Number: 58051
Lot Numbers: 40414-0325, 40722-0328, 40918-0321, 40414-0325, 40305-0325, 31216-0158
ARTG Number: 135457
Recall Action Level
Hospital
Recall Action Classification
Class III
Recall Action Commencement Date
16/11/2015
Responsible Entity
Medtel Pty Ltd
Reason/Issue
It was discovered that there is a risk that the abovementioned affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date. It is very unlikely that this will cause a patient risk.
Recall Action
Recall
Recall Action Instructions
Medtel is advising users to inspect stock and quarantine any remaining units. Affected product will be replaced by unaffected units. This action has been closed-out on 25/08/2016.
Contact Information
02 9413 6212 - Medtel