| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00904-1 |
| Product Name/Description |
OXYGEN Sterile Protection
Part Number: 60200
Lot/batch No.: 201401 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
In a limited number of the product, OXYGEN Sterile Protection (PN: 60200), a protective cover foil that protects the transparent part of the lens hood system is not removed at some pieces. Independent testing undertaken by the manufacturer has indicated that sterility of the product may not be breached despite the presence of protective cover foil, |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospitals were advised that if they find any products with the green film still attached to the visor to put it aside and Danex Medical Pty Ltd will collect and replace the lens hoods at no charge.
This action was undertaken prior to the notification to the TGA.
This action has been closed-out on 11/11/2016. |
| Contact Information |
02 8883 3101 - Danex Medical Pty Ltd |