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 Davol Inc Subsidiary of C R Bard Inc PerFix Plug, PerFix Light Plug, Ventralex Hernia Patch and Bard Mesh [Product codes: 0112750, 0112760, 0112770, 0112780, 0112950, 0112960, 0010301, 0010302, 0010303, 0117050, 0117060, 0117070, 0117080, 0117150, 0117160, 0117170, 0117180, 0112640, 0112650, 0112660, 0112670, 0112680 and 0112720] [HKMD No.: 180200].
According to the TGA, in 2018, it has announced regulatory amendments to reclassify medium risk (Class IIB) surgical mesh devices to high risk (Class III). As part of the reclassification exercise, the following changes to the instructions for use (IFU), patient information leaflet (PIL) and/or labelling will be implemented for our reclassified surgical mesh devices.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00172-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 Mar 2023