Field Safety Notice Cook Medical Labelling Expiration Dates Various Products (ICN 3277)

NHSSC: 115

Alert:

• Cook Medical has issued Field Safety Notice FSN (FSCA Ref: 2026FA0001) having identified a number of products, listed in ‘Attachment 1 – Product Information Table’ have been labelled with expiration dates that exceed the true shelf life.
• Cook Medical advises the issue was identified internally during Quality Assurance procedures and IT software validations.
• Potential adverse events that may occur if an affected product is used after its true expiration date include increased procedural time, pain/discomfort, tissue injury, infection, harms associated with device fragmentation/separation, harms associated with a non-biocompatible device, and harms associated with coating flaking off.
• Cook Medical advises to date; they have received no customer complaints of adverse patient effects related to this issue.

Products Affected:

• Nine products are affected.
• Six affected products with these lot numbers have been sold via NHS Supply Chain’s eDirect service.
• Please note only the products and lot numbers listed in ‘Attachment 1’ are affected.
• Please see the attached product listing and Field Safety Notice for more information and details on the affected products.

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 with the lot numbers listed in Attachment 1.
• Complete the Customer Reply Form and email to: FieldAction@CookMedical.com
• Where product is indicated as being available for return, Cook Medical’s Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization Number.
• Please also contact your local NHS Supply Chain Customer Service Advisor with details of the products for collection by Cook Medical, together with the Returns Authorization Number, to enable us to manage your credit.
• Cook Medical confirm they have identified and already contacted all affected customers.

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.