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 MEDEX SECUFILL patient lines X50 [Product Code: SECU002; Batch Number: LX221001; Expiry Dates: 07/03/2025] [HKMD No.: 140033].
According to the TGA, due to the potential for burr particulate formation and subsequent intravascular injection, the manufacturer has decided to recall identified batches of SecuFill patient lines.
The particulates originate from the protective cap used in the assembly of the device. During internal controls performed some of these particulates have been observed on the Luer-lock of some units.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-01097-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Dec 2023