| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00207-1 |
| Product Name/Description |
Fresenius Medical Care Haemodialysis Machines Series 4008/5008/6008
Model numbers: M200301, M200401, M201701, M200661, M200861, M201011, M201211
ARTG's 120309, 257513 & 272584 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Fresenius Medical Care (FMC) have identified that the disinfectants stated in the IFU for FMC dialysis machines are not currently available in Australia and therefore FMC are notifying users of interim cleaning agents. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Apart from the common use of 1% sodium hypochlorite (common bleach), several universal disinfectants are cleared for use by the TGA as instrument grade and suitable for use with medical devices. These disinfectants have been assessed as effective against infectious and deemed safe for use. Some of these are supplied as ‘wipes or sprays/liquids and are ARTG listed hence readily available in Australia.
Disinfectant solutions/wipes must be near or pH neutral to ensure they are not corrosive, decreasing the likelihood of excessive deterioration of the dialysis machines & equipment surfaces overtime. ARTG listed disinfectants that contain Alcohol or cationic surfactants are believed to be the least likely to impact device surfaces overtime due to them being neither strongly corrosive nor acidic.
Customers should seek an alternative disinfectant which has been cleared by the TGA for use on medical devices being mindful of the above. |
| Contact Information |
0428 092 132 - Patrick Gregson |