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 the Stryker Corporation Stryker Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. [REF: CAT00241; Lot # 007047/UDI: 07613252632863] [HKMD No.: 180188].
According to the FDA, expired product was distributed.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93140
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Nov 2023