Device Safety Information – DSI2/006/002

The Namic Angiographic Control Syringes with RA (‘Namic RA syringes’), and the Namic White Star Off Handle Manifold (‘Namic White Star Manifolds’) are components supplied in certain Kimal procedure packs distributed in the UK and used by healthcare professionals in the UK primarily for diagnostic and interventional cardiology and radiology procedures. Since April 2026, Medline International France and Kimal PLC have identified potential safety issues with these devices and have issued field safety notices to all affected hospitals in the UK advising that they should not be used except in emergency situations. The rotating adaptor in affected Namic syringes may unscrew (become loose) during use, due to a manufacturing issue that causes a loose connection and/or full disconnection between the syringe and the manifold. There may be a risk of foreign particulates within the fluid pathway of affected Namic Manifolds. Replacement Namic Manifolds are expected to be available from June 2026 onwards, but this is not guaranteed.

Healthcare professionals who consider continued use of the impacted products within the Kimal procedure packs necessary should carefully assess and implement the following risk mitigation measures when using the impacted products.