Field Safety Notice Cook Medical Beacon® Tip 5.0 Fr Angiographic Catheter (ICN 2954)

NHSSC: 18

Alert:

• Cook Medical has issued a Field Safety Notice dated 13 May 2025 regarding specific lots of Beacon® Tip 5.0 Fr Angiographic Catheters.
• The supplier identified that catheters supplied in the affected device lots may experience tip separation.
• Potential adverse events that may occur if an affected product is used include harms associated with device fragmentation/separation and vessel injury.

Products Affected:

• 16 of the affected products are available from NHS Supply Chain.
• Please see the attached product listing and Attachment 1 for more information of the products impacted.
• Please note only the lot numbers noted in Attachment 1 are affected.
• Future orders will be fulfilled with unaffected lots.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• Complete the Customer Response Form and return to FieldAction@CookMedical.com to arrange collection of affected products.
• Please also contact your NHS Supply Chain Customer Service Advisor with full details, including quantities and lot numbers you are returning to the supplier to enable us to manage your credit where appropriate.
• Cook Medical may have already been in contact with you surrounding this notice. If you have already actioned and required credit, please contact your NHS Supply Chain Customer Service Advisor.

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