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 BALT USA, LLC Optima Coil System [Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068; Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089] [HKMD No.: 180284].
According to the FDA, the product pouch label does not match up with carton label.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=90870
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Oct 2022