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 United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Merit Medical Systems, Inc. Prelude Sheath Introducer 7.5F [Ref: PSI-7F-11-038 Version F (PSI-7F-11-038/F)] [HKMD No.: 180077].
According to the FDA, 7F sheath introducers labeled as 7.5F.
For further information, please visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=95234
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Sep 2024