| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00266-1 |
| Product Name/Description |
Fluoron Gas Tamponades (Intraocular injection of ophthalmic gases)
Models: EasyGas Sulphur Hexafluoride (SF6), EasyGas Hexafluoroethane (C2F6), EasyGas Octafluoropropane (C3F8)
Lot Numbers: G-80950, G-80960 & G-80970
ARTG Number: 197089 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports where the tamponades have displayed a potential loss of gas volume due to the design of the syringe packaging. |
| Recall Action |
Recall |
| Recall Action Instructions |
IQ Medical is asking customers to quarantine all affected units, if any remaining in the field and return any remaining units. |
| Contact Information |
08 8357 8022 - IQ Medical |