The MHRA has updated guidance for UK hospitals using Namic angiographic control syringes and Namic White Star manifolds supplied within certain Kimal procedure packs.
A manufacturing issue can allow the rotating adaptor on an affected syringe to loosen or disconnect. The regulator also identifies a risk of foreign particles in the fluid pathway of affected manifolds used mainly in diagnostic and interventional cardiology or radiology.
Hospitals are advised not to use the affected components except in urgent procedures when no alternative is available. Where continued use is judged necessary, clinicians should follow the manufacturer's updated field-safety notices and the MHRA's risk-mitigation steps.
Providers should identify affected stock, apply supplied warnings where required and report device incidents through the appropriate channel. The notice distinguishes urgent use from routine use and does not describe the products as generally safe for continued deployment.
