Field Safety Notice Poly Medicure Fannin Autofusion Enhance IV Sets FBO85009 (ICN 2934)

NHSSC: 15

Alert:

• Poly Medicure has instructed Fannin to quarantine two batches of the Autofusion Enhance IV sets as a precautionery measure following reports of the product not functioning as designed sporadically/randomly.
• This will enable Poly Medicure to inspect the products and conduct an investigation to establish the cause.
• Until the root cause is established customers are requested to return the two affected batches.

Products Affected:

• The product affected is available from NHS Supply Chain’s stocked route:

• Please note only the batch numbers quoted in the Advisory Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Poly Medicure confirm there is no impact on availability, future orders will be fulfilled with unaffected batch numbers.

Next Steps:

• Read and follow the full instructions in the Advisory Notice and share with all users of the affected products.
• Customers are requested to cease use and quarantine all affected batches.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, reason code – 7 (Supplier Recall). All products to be returned no later than Friday 6 June 2025.

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.