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 Medtronic Neurosurgery Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only [Lot Number: 226632942; UDI-DI: 00763000624781] [HKMD No.: 140325].
According to FDA, product labeling contains incorrect expiration date.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92702
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Aug 2023