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.
Medical device manufacturer, Covidien llc has issued a medical device safety alert concerning its Salem Sump Tubes [Product code: 8888264929, 8888266114, 8888264945, 8888266122, 8888264960, 8888266130, 8888264986ΒΈ 8888266148] [HKMD No.: 140042].
The manufacturer has updated its product labeling for the Salem Sump products in response to reported incidences of improper use of the device, which can lead to breakage of the Salem Sump Anti-Reflux Valve (ARV). These changes to the labeling include creation of an electronic IFU and the addition of the eIFU symbol to the packaging labels. These changes will assist in increasing user awareness of proper device usage and decrease the risk of potential patient harm due to device replacement.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 Aug 2024