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 Merit Medical Systems, Inc. Merit Maestro Microcatheter [Product code: 28MC24150ST/F; Lot Number: H2749681] [HKMD No.: 120273].
According to TGA, the manufacturer is conducting a recall of specific Merit Maestro Microcatheter lots due to a supplier packaging defect. Specifically, the gold foil pouch holding the catheter may contain a small hole along the pouch seal. This hole may impact the sterility of the device.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00966-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Nov 2023