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 Bard PowerPICC 5Fr SL IR 135cm, PowerPICC 6Fr TL IR 135cm, PowerPICC SV 4F DL Sherlock, PowerPICC SOLO 5Fr DL IR 70cm and Groshong PICC 4F SL Bas [Product codes: 6175335, 6386335, 22274118, 6295355 and 7617405; Lot numbers: REFW2435, REFX3565, REFY3746, REGS3098 and REGW0814] [HKMD No.: 100039].
According to the TGA, the manufacturer has identified that specific products have been distributed to market without the required Patient Information Leaflet. The risk of harm from the hazardous situation is negligible.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00912-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Oct 2023