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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00040-1
Product Name/Description Medicina Keyhole Dressing KDXX

ARTG Number: 129372
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/01/2015
Responsible Entity Australasian Medical & Scientific Ltd
Reason/Issue Australasian Medical& Scientific Ltd (AMSL) is informing their customers that the safety and performance of these devices have not been properly evaluated and so the CE marking of the device is not valid
Recall Action Recall
Recall Action Instructions AMSL is requesting the customers to inspect the stock and quarantine all units. AMSL will arrange for the affected stock to be recovered and a credit note issued. This action has been closed-out on 15/07/2016.
Contact Information 02 9882 3666 - AMSL