| 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 |
|
| 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 |