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 Argon Medical Devices, Inc. BioPince, BioPince Ultra and Tru-Core II Automatic Biopsy Instruments [Multiple products and lot numbers] [HKMD No.: 240207].
According to the TGA, holes have been identified in the packaging trays which may compromise the sterile barrier of the device. Non-sterile product potentially exposes patients to the introduction of micro-organisms into the access site, leading to an infectious process, bacteraemia, or sepsis. There is also a risk of cross contamination if the device is used with another product or on a sterile field.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00565-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Identified on 17 Jul 2024