Safety Alerts
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.
Medical Device Safety Alert: Bentley InnoMed GmbH (Device Technologies Australia Pty Ltd) BEGRAFT AORTIC STENT SYS and BEGRAFT PERIPHERAL STENT
21 Nov 2024
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Bentley InnoMed GmbH (Device Technologies Australia Pty Ltd) BEGRAFT AORTIC STENT SYS and BEGRAFT PERIPHERAL STENT [Multiple product codes and lot numbers] [HKMD No.: 160495, 170083].
According to the TGA, it was found that a number of supplied products had incorrect country specific labelling. For these products there is additional labelling attached to the exterior packaging which is not compliant with the regulatory requirements for Australia. In addition, the sponsor label and link to ePIL is missing. The products themselves as well as the content within the product box and the product specific labelling (e.g. REF, Lot, manufacturing date, expiration date) on the affected products are correct.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-01029-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Nov 2024