Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Fresenius Medical Care AG & Co. KGaA Fresenius Medical Care Haemodialysis Machines Series 4008/5008/6008 [Model numbers: M200301, M200401, M201701, M200661, M200861, M201011, M201211] [HKMD Number: 120607].
According to the TGA, the manufacturer has identified that the disinfectants stated in the IFU for FMC dialysis machines are not currently available in Australia and therefore the manufacturer is notifying users of interim cleaning agents.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00207-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Mar 2024