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 Covidien Step Bladeless Trocars (Product Number S101010), Chromic Gut Absorbable Sutures, Mild Chromic Gut Absorbable Sutures, and Plain Gut Absorbable Sutures [HKMD No.: 120364 and 120518]
According to the FDA, the manufacturer has was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. The use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=91873
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Apr 2023