Field Safety Notice Medex Secufill Contrast Media Injector Options Secufill JAH328 (ICN 2406)

Alert:

• Medex (A Guerbet Group Company) has issued a Field Safety Notice for specific Lots of Secufill due to the potential for burr particulate formation and subsequent intravascular injection.
• In case some particulates are injected intravenously, they could cause organ damage potentially resulting in serious patient injury.

Products Affected:

• The affected product is available from NHS Supply Chain:

• Please note only the Lot numbers quoted on page three of the Field Safety Notice, issued by Medex are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use of all affected products.
• Complete Appendix 2, pages four and five of the Field Safety Notice, and return by emailing: sales@guerbet.com
• Contact your NHS Supply Chain Customer Service Advisor or the Hospital Care Team with full details of the quantity of affected products in your possession including the Lot numbers, and whether the quantity is in eaches or boxes of 50 to enable us to support or raise credit if appropriate.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.
• 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 or 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.