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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