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 BALT Extrusion SAS Hybrid Guidewire (HYBRIDE12D300) [Lot numbers: All lot number] [HKMD No.: 210339].
According to the TGA, an error on the HYBRID12D300 guidewire drawing on both the pouch and box labels has been identified. The length of the radio-opaque distal tip drawing indicates a 3cm long marker instead of 8cm. The written dimensions contain the correct measurements.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00830-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Sep 2023