| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00260-1 |
| Product Name/Description |
NON REBREATHE MASK
Product Code: WL-PB23401-1V
Batch Numbers: 1703020228 and 1703020368
ARTG Number: 133120
(Device Technologies Australia - Mask, non-rebreathing, air/oxygen) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Well Lead Medical Co Ltd, have identified that certain batches where the oxygen tubing might detach from the connector.
There have been no injuries associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies is advising users to inspect stock and quarantine remaining stock of the affected batches. Affected stock can be returned to Device Technologies and a credit note issued.
This action has been closed out on 05/11/2018 |
| Contact Information |
02 9972 8367 - Customer Service Support |