Field Safety Notice Kimal Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes (ICN 3326)

NHSSC: 3

Alert:

• Kimal has made us aware of three Field Safety Notices issued by Medline regarding the recall of specific batches of Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes.
• Medline has identified through post-market surveillance:
  • For affected Namic Angiographic Control Syringe with Rotating Adaptor (RA) fitting (Namic RA Syringes) a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold
  • For affected Namic White Star Handle Manifolds, identified a potential risk of foreign particulate within the fluid pathway of Namic White Star Manifolds.

Products Affected:

• We are working with Kimal to identify all affected products supplied by NHS Supply Chain.
• Some of the affected products are contained within procedure packs.
• Please refer to the three Medline Field Safety Notices for more information on the affected products in the meantime.

Next Steps:

• Read and follow the full instructions in the Field Safety Notices and share with all users of the affected products.
• For support regarding this recall please contact vigilance@kimal.com.
• Should you wish to return any affected products, please contact Kimal to arrange collection and inform your NHS Supply Chain Customer Service Advisor with full details to enable us to raise the appropriate credit.
• We are working with the supplier to support product availability and will update this ICN with more information as soon as possible.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.