| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01327-1 |
| Product Name/Description |
Fluoron Gas Tamponade EasyGas SF6
Item Number: G-80950
Lot Numbers: EG1 300614 and EG1 150714
ARTG Number: 197089 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Fluoron GmbH is voluntarily recalling the product due to a potential incorrect bottling of the longer acting gas C3F8 (12%) instead of SF6 (20%). |
| Recall Action |
Recall |
| Recall Action Instructions |
IQ Medical is requesting surgeons/healthcare professionals to notify their patients who received the affected products about the resulting extended prohibition of flying, diving and anaesthesia using nitrous oxide of 60 days from treatment. IQ Medical is also recalling any remaining stock in the market. This action has been closed-out on 08/03/2016. |
| Contact Information |
08 8357 8022 - IQ Medical Pty Ltd |