Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00042-1
Product Name/Description Medicina Low Profile Gastrostomy Button

All batches

Order code: MD-BXX/XX-01

ARTG No. 128376
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/01/2015
Responsible Entity Australasian Medical & Scientific Ltd
Reason/Issue Australasian Medical & Scientific Ltd (AMSL) is informing the 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