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 Cook Incorporated Check-Flo Performer Introducer Set [HKMD number: 230187].
According to the TGA, devices from lot 15506769 may have white caps that connect the shaft to the hub of the products that may disconnect. There is a possibility that this may result in an increased procedural time, harms associated with device fragmentation/separation, and/or haemorrhaging/blood loss.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00821-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Sep 2024