Field Safety Notice Poly Medicure Fannin IV Fluid Infusion Set FSB2116 (ICN 3333)

NHSSC: 09

Alert:

• Poly Medicure has issued a Field Safety Notice following reports of leakage of the Fannin IV Fluid Infusion Set during use. The leakage was observed at the junction between the Back Check Valve (BCV) and stopcock of the extension line.
• The Back Check Valve is designed to prevent backflow and reduce the risk of contamination or unintended fluid movement.
• Leakage at the Back Check Valve (BCV) joint may lead to interruption or under-delivery of infusion, potential air ingress into the infusion line, and fluid leakage during administration.
• Poly Medicure advise the clinical impact is considered potentially low to moderate, depending on the type of fluid or medication being administered and the clinical context of use.
• To date, Poly Medicure has received no reports of serious patient harm.

Products Affected:

• One product is affected.
• The product affected is available via NHS Supply Chain:

• Please refer to Annex II, page 5 of the Field Safety Notice for the full list of affected batch numbers.
• Please note only the batch numbers quoted in the Field Safety Notice are affected.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock.

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 batches.
• Contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products for return using reason code 7 – Supplier Recall.
• All goods must be returned no later than Friday 5 June 2026.

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.