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 Sofsilk Braided Silk Suture and Surgilon Coated Braided Nylon Nonabsorbable Suture [HKMD No.: 110197, 160332].
The manufacturer determined that specific lots of the Sofsilk Braided Silk sutures and Surgilon Coated Braided Nylon Nonabsorbable Suture were sterilized with gamma doses that exceeded the range approved. The affected lots were released between September 2022 and March 2023. The expected impact on the tensile strength of these sutures will develop overtime throughout their labelled shelf life.
The extra gamma levels have the potential to decrease the strength of these sutures over time which could result in harms such as wound dehiscence and hemorrhage/blood loss/bleeding at a critical level.
For further information, please visit https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20240104144625181.html
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 Dec 2023
Updated on 5 Jan 2024