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 Baxter Healthcare SA Seprafilm Adhesion Barrier [1 Half Sheet, 5-PK, REF: 664103; UDI/DI: 05413765588310, Lot Number: DBYSEP046] [HKMD No.: 220049].
According to the FDA, product was distributed in the United States without proper regulatory approval.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=94298
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Apr 2024